As we head into the last few weeks of the first session of the 115th Congress, it is likely that several pieces of “must pass” legislation will move through the process of becoming law. This “must pass” legislation can serve as a vehicle onto which other bills are attached and thus, also move successfully through the process for passage. I have highlighted below three such bills from the Action Alert section of the SurgeonsVoice website (www.surgeonsvoice.com) which could, with less than 5 minutes of your time, develop enough forward momentum to so move.

Ensuring Access to General Surgery Act

Increasing evidence indicates a current and growing shortage of surgeons available to serve our nation’s population. A shortage of general surgeons is a critical component of the crisis in health care workforce because only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize, through the designation of a formal surgical shortage area, that surgeons are an essential component of a community based health care system.

Mission Zero Act

It has long been a priority of the ACS to establish and maintain high-quality and adequately-funded trauma systems throughout the U.S., including within the Armed Forces. The Mission Zero Act, introduced by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Gene Green (D-TX), Richard Hudson (R-NC), and Kathy Castor (D-FL) in the House of Representatives and Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL) in the Senate, would provide HHS grant funding to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality trauma care. As a result of these partnerships, military trauma care teams and providers will gain exposure treating critically injured patients and increase readiness for future deployments. Not only will this serve to maintain readiness among military providers, but it will facilitate the promulgation of the trauma lessons learned from the military theatres of conflict to the civilian world and potentially alleviate staffing shortages in civilian centers.

CHIP Funding

The Children’s Health Insurance Program (CHIP) is a joint federal and state program that provides health coverage to uninsured children from low-income families. In 2015, the CHIP program provided coverage to over 8 million children in the United States. In sum, CHIP ensures that these children have access to care. The ACS is very supportive of the CHIP program. The CHIP program ensures that a child’s health care concerns are addressed in a timely manner. Contrary to popular belief, many children currently covered by CHIP are not eligible to be covered under Medicaid and would therefore, be left uninsured if CHIP funding is not continued. The most recent reauthorization of this program extended funding for the CHIP program through Sept. 30, 2017, and funding for the program expired on that date. Urgent Congressional action is needed to reauthorize funding and thus, ensure that the children covered by CHIP continue to have access to the health care services they need.

The ACS strongly urges Congress to continue to make children’s health care a priority issue and accordingly, implores Congress to take action to reauthorize CHIP funding prior to concluding the business of the current session.

The SurgeonsVoice website provides an easy and efficient platform for surgeons to use to contact their senators and their representative to let them know of their support of these issues. Taking action on all three of these items would require the investment of less than 5 minutes of one’s valuable time. Our ability “to petition the government for a redress of grievances” is guaranteed by the First Amendment. I urge all Fellows to visit the SurgeonsVoice website and use it as a tool to exercise that right.

Until next month ….

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.

As we head into the last few weeks of the first session of the 115th Congress, it is likely that several pieces of “must pass” legislation will move through the process of becoming law. This “must pass” legislation can serve as a vehicle onto which other bills are attached and thus, also move successfully through the process for passage. I have highlighted below three such bills from the Action Alert section of the SurgeonsVoice website (www.surgeonsvoice.com) which could, with less than 5 minutes of your time, develop enough forward momentum to so move.

Ensuring Access to General Surgery Act

Increasing evidence indicates a current and growing shortage of surgeons available to serve our nation’s population. A shortage of general surgeons is a critical component of the crisis in health care workforce because only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize, through the designation of a formal surgical shortage area, that surgeons are an essential component of a community based health care system.

Mission Zero Act

It has long been a priority of the ACS to establish and maintain high-quality and adequately-funded trauma systems throughout the U.S., including within the Armed Forces. The Mission Zero Act, introduced by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Gene Green (D-TX), Richard Hudson (R-NC), and Kathy Castor (D-FL) in the House of Representatives and Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL) in the Senate, would provide HHS grant funding to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality trauma care. As a result of these partnerships, military trauma care teams and providers will gain exposure treating critically injured patients and increase readiness for future deployments. Not only will this serve to maintain readiness among military providers, but it will facilitate the promulgation of the trauma lessons learned from the military theatres of conflict to the civilian world and potentially alleviate staffing shortages in civilian centers.

CHIP Funding

The Children’s Health Insurance Program (CHIP) is a joint federal and state program that provides health coverage to uninsured children from low-income families. In 2015, the CHIP program provided coverage to over 8 million children in the United States. In sum, CHIP ensures that these children have access to care. The ACS is very supportive of the CHIP program. The CHIP program ensures that a child’s health care concerns are addressed in a timely manner. Contrary to popular belief, many children currently covered by CHIP are not eligible to be covered under Medicaid and would therefore, be left uninsured if CHIP funding is not continued. The most recent reauthorization of this program extended funding for the CHIP program through Sept. 30, 2017, and funding for the program expired on that date. Urgent Congressional action is needed to reauthorize funding and thus, ensure that the children covered by CHIP continue to have access to the health care services they need.

The ACS strongly urges Congress to continue to make children’s health care a priority issue and accordingly, implores Congress to take action to reauthorize CHIP funding prior to concluding the business of the current session.

The SurgeonsVoice website provides an easy and efficient platform for surgeons to use to contact their senators and their representative to let them know of their support of these issues. Taking action on all three of these items would require the investment of less than 5 minutes of one’s valuable time. Our ability “to petition the government for a redress of grievances” is guaranteed by the First Amendment. I urge all Fellows to visit the SurgeonsVoice website and use it as a tool to exercise that right.

Until next month ….

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.

As we head into the last few weeks of the first session of the 115th Congress, it is likely that several pieces of “must pass” legislation will move through the process of becoming law. This “must pass” legislation can serve as a vehicle onto which other bills are attached and thus, also move successfully through the process for passage. I have highlighted below three such bills from the Action Alert section of the SurgeonsVoice website (www.surgeonsvoice.com) which could, with less than 5 minutes of your time, develop enough forward momentum to so move.

Ensuring Access to General Surgery Act

Increasing evidence indicates a current and growing shortage of surgeons available to serve our nation’s population. A shortage of general surgeons is a critical component of the crisis in health care workforce because only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize, through the designation of a formal surgical shortage area, that surgeons are an essential component of a community based health care system.

Mission Zero Act

It has long been a priority of the ACS to establish and maintain high-quality and adequately-funded trauma systems throughout the U.S., including within the Armed Forces. The Mission Zero Act, introduced by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Gene Green (D-TX), Richard Hudson (R-NC), and Kathy Castor (D-FL) in the House of Representatives and Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL) in the Senate, would provide HHS grant funding to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality trauma care. As a result of these partnerships, military trauma care teams and providers will gain exposure treating critically injured patients and increase readiness for future deployments. Not only will this serve to maintain readiness among military providers, but it will facilitate the promulgation of the trauma lessons learned from the military theatres of conflict to the civilian world and potentially alleviate staffing shortages in civilian centers.

CHIP Funding

The Children’s Health Insurance Program (CHIP) is a joint federal and state program that provides health coverage to uninsured children from low-income families. In 2015, the CHIP program provided coverage to over 8 million children in the United States. In sum, CHIP ensures that these children have access to care. The ACS is very supportive of the CHIP program. The CHIP program ensures that a child’s health care concerns are addressed in a timely manner. Contrary to popular belief, many children currently covered by CHIP are not eligible to be covered under Medicaid and would therefore, be left uninsured if CHIP funding is not continued. The most recent reauthorization of this program extended funding for the CHIP program through Sept. 30, 2017, and funding for the program expired on that date. Urgent Congressional action is needed to reauthorize funding and thus, ensure that the children covered by CHIP continue to have access to the health care services they need.

The ACS strongly urges Congress to continue to make children’s health care a priority issue and accordingly, implores Congress to take action to reauthorize CHIP funding prior to concluding the business of the current session.

The SurgeonsVoice website provides an easy and efficient platform for surgeons to use to contact their senators and their representative to let them know of their support of these issues. Taking action on all three of these items would require the investment of less than 5 minutes of one’s valuable time. Our ability “to petition the government for a redress of grievances” is guaranteed by the First Amendment. I urge all Fellows to visit the SurgeonsVoice website and use it as a tool to exercise that right.

Until next month ….

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.

WASHINGTON – Data are accumulating that lend more support to a one-step approach for diagnosing gestational diabetes mellitus in the United States.

The American College of Obstetricians and Gynecologists now acknowledges this approach as an option, yet “tremendous controversy persists,” according to Mark Landon, MD.

“In the U.S., we continue to be the principal purveyors of a two-step method with a 100-g [oral glucose tolerance test] diagnostic approach, which is in contrast to much of the rest of the world,” he said the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“At this time, if we’re going to [turn nationally] to the one-step approach, we have to lower the cost of diagnosis and treatment, and we may need some upwards adjustments in the [International Association of Diabetes and Pregnancy Study Groups] criteria in order to achieve consensus,” said Dr. Landon, professor and chair of the department of obstetrics and gynecology at Ohio State University, Columbus.

The International Association of Diabetes in Pregnancy Study Groups (IADPSG) created a stir in the American obstetrics community when it recommended in 2010 that a universal 75-g, 2-hour oral glucose tolerance test (OGTT) be performed during pregnancy and that gestational diabetes mellitus (GDM) be diagnosed when any single measurement threshold – a fasting value of 92 mg/dL, a 1-hour value of 180 mg/dL, or a 2-hour value of 153 mg/dL – is met or exceeded (Diabetes Care 2010 Mar; 33[3]:676-82).

The consensus group made its recommendation based largely on published associations of maternal glycemia with perinatal and long-term outcomes in offspring. Chief among the studies was the landmark Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, which found continuous linear relationships between maternal glucose levels – including levels that had been viewed as normal – and adverse fetal outcomes such as high fetal birth weight, cord-blood serum C-peptide level (an index of fetal beta-cell function and fetal hyperinsulinemia), and clinical neonatal hypoglycemia. Maternal glucose tolerance was measured in the study with the 75-g 2-hour OGTT.

The IADPSG chose its cut-off points to convey an odds ratio for adverse outcomes of 1.75. But use of the criteria meant that 16%-18% of pregnant women in the United States would be identified as having GDM – a doubling, at least.

Courtesy Ohio State University

WASHINGTON – Data are accumulating that lend more support to a one-step approach for diagnosing gestational diabetes mellitus in the United States.

The American College of Obstetricians and Gynecologists now acknowledges this approach as an option, yet “tremendous controversy persists,” according to Mark Landon, MD.

“In the U.S., we continue to be the principal purveyors of a two-step method with a 100-g [oral glucose tolerance test] diagnostic approach, which is in contrast to much of the rest of the world,” he said the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“At this time, if we’re going to [turn nationally] to the one-step approach, we have to lower the cost of diagnosis and treatment, and we may need some upwards adjustments in the [International Association of Diabetes and Pregnancy Study Groups] criteria in order to achieve consensus,” said Dr. Landon, professor and chair of the department of obstetrics and gynecology at Ohio State University, Columbus.

The International Association of Diabetes in Pregnancy Study Groups (IADPSG) created a stir in the American obstetrics community when it recommended in 2010 that a universal 75-g, 2-hour oral glucose tolerance test (OGTT) be performed during pregnancy and that gestational diabetes mellitus (GDM) be diagnosed when any single measurement threshold – a fasting value of 92 mg/dL, a 1-hour value of 180 mg/dL, or a 2-hour value of 153 mg/dL – is met or exceeded (Diabetes Care 2010 Mar; 33[3]:676-82).

The consensus group made its recommendation based largely on published associations of maternal glycemia with perinatal and long-term outcomes in offspring. Chief among the studies was the landmark Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, which found continuous linear relationships between maternal glucose levels – including levels that had been viewed as normal – and adverse fetal outcomes such as high fetal birth weight, cord-blood serum C-peptide level (an index of fetal beta-cell function and fetal hyperinsulinemia), and clinical neonatal hypoglycemia. Maternal glucose tolerance was measured in the study with the 75-g 2-hour OGTT.

The IADPSG chose its cut-off points to convey an odds ratio for adverse outcomes of 1.75. But use of the criteria meant that 16%-18% of pregnant women in the United States would be identified as having GDM – a doubling, at least.

Courtesy Ohio State University

WASHINGTON – Data are accumulating that lend more support to a one-step approach for diagnosing gestational diabetes mellitus in the United States.

The American College of Obstetricians and Gynecologists now acknowledges this approach as an option, yet “tremendous controversy persists,” according to Mark Landon, MD.

“In the U.S., we continue to be the principal purveyors of a two-step method with a 100-g [oral glucose tolerance test] diagnostic approach, which is in contrast to much of the rest of the world,” he said the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“At this time, if we’re going to [turn nationally] to the one-step approach, we have to lower the cost of diagnosis and treatment, and we may need some upwards adjustments in the [International Association of Diabetes and Pregnancy Study Groups] criteria in order to achieve consensus,” said Dr. Landon, professor and chair of the department of obstetrics and gynecology at Ohio State University, Columbus.

The International Association of Diabetes in Pregnancy Study Groups (IADPSG) created a stir in the American obstetrics community when it recommended in 2010 that a universal 75-g, 2-hour oral glucose tolerance test (OGTT) be performed during pregnancy and that gestational diabetes mellitus (GDM) be diagnosed when any single measurement threshold – a fasting value of 92 mg/dL, a 1-hour value of 180 mg/dL, or a 2-hour value of 153 mg/dL – is met or exceeded (Diabetes Care 2010 Mar; 33[3]:676-82).

The consensus group made its recommendation based largely on published associations of maternal glycemia with perinatal and long-term outcomes in offspring. Chief among the studies was the landmark Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, which found continuous linear relationships between maternal glucose levels – including levels that had been viewed as normal – and adverse fetal outcomes such as high fetal birth weight, cord-blood serum C-peptide level (an index of fetal beta-cell function and fetal hyperinsulinemia), and clinical neonatal hypoglycemia. Maternal glucose tolerance was measured in the study with the 75-g 2-hour OGTT.

The IADPSG chose its cut-off points to convey an odds ratio for adverse outcomes of 1.75. But use of the criteria meant that 16%-18% of pregnant women in the United States would be identified as having GDM – a doubling, at least.

Courtesy Ohio State University

Click here to access Optimal Treatments for Cardiovascular Diseases

Table of Contents

• Roundtable Discussion : Anticoagulation Management
• The Pharmacist’s Role in Medication Optimization for Patients With Chronic Heart Failure
• Pharmacist Interventions to Reduce Modifiable Bleeding Risk Factors Using HAS-BLED in Patients Taking Warfarin

Click here to access Optimal Treatments for Cardiovascular Diseases

Table of Contents

• Roundtable Discussion : Anticoagulation Management
• The Pharmacist’s Role in Medication Optimization for Patients With Chronic Heart Failure
• Pharmacist Interventions to Reduce Modifiable Bleeding Risk Factors Using HAS-BLED in Patients Taking Warfarin

Click here to access Optimal Treatments for Cardiovascular Diseases

Table of Contents

• Roundtable Discussion : Anticoagulation Management
• The Pharmacist’s Role in Medication Optimization for Patients With Chronic Heart Failure
• Pharmacist Interventions to Reduce Modifiable Bleeding Risk Factors Using HAS-BLED in Patients Taking Warfarin

More than half a million people committed suicide between 2001 and 2015, according to the CDC. Rural counties consistently had higher rates than those of metropolitan areas. “While we’ve seen many causes of death come down in recent years, suicide rates have increased more than 20% from 2001 to 2015,” said Brenda Fitzgerald, MD, CDC director. “And this is especially concerning in rural areas.”

Related: Suicide Federal Health Data Trends

Suicide rates in rural counties were 17.32 per 100,000 people compared with 14.86 in small-to-medium metropolitan counties and 11.92 in large metropolitan counties. Rates for American Indian/Alaska Native non-Hispanics were the highest.

The researchers note that, at some points, different negative factors had more impact. For instance, rural communities were harder hit by housing foreclosures, poverty, and unemployment due to the recession. However, the researchers also point out that suicide rates were on the rise before the recession began.

“The trends in suicide rates…are magnified in rural areas,” said James Mercy, PhD, director of CDC’s Division of Violence Prevention. “This report underscores the need for suicide prevention strategies that are specifically tailored for these communities.” To that end, the CDC recently released a compilation of evidence-based strategies that have the greatest prevention potential. The set includes examples of programs that can be customized to fit the cultural needs of different groups. In North Dakota, for instance, the program Sources of Strength was developed for tribal communities to promote connectedness between youth and adults.

Related: Improving Veteran Engagement With Mental Health Care

The Health Resource and Service Administration (HRSA) also has developed activities to address suicide in rural areas, including epidemiologic studies, research, telemedicine, and programs addressing primary health care providers.

https://www.cdc.gov/violenceprevention/pub/technical-packages.html

https://www.hrsa.gov/ruralhealth

More than half a million people committed suicide between 2001 and 2015, according to the CDC. Rural counties consistently had higher rates than those of metropolitan areas. “While we’ve seen many causes of death come down in recent years, suicide rates have increased more than 20% from 2001 to 2015,” said Brenda Fitzgerald, MD, CDC director. “And this is especially concerning in rural areas.”

Related: Suicide Federal Health Data Trends

Suicide rates in rural counties were 17.32 per 100,000 people compared with 14.86 in small-to-medium metropolitan counties and 11.92 in large metropolitan counties. Rates for American Indian/Alaska Native non-Hispanics were the highest.

The researchers note that, at some points, different negative factors had more impact. For instance, rural communities were harder hit by housing foreclosures, poverty, and unemployment due to the recession. However, the researchers also point out that suicide rates were on the rise before the recession began.

“The trends in suicide rates…are magnified in rural areas,” said James Mercy, PhD, director of CDC’s Division of Violence Prevention. “This report underscores the need for suicide prevention strategies that are specifically tailored for these communities.” To that end, the CDC recently released a compilation of evidence-based strategies that have the greatest prevention potential. The set includes examples of programs that can be customized to fit the cultural needs of different groups. In North Dakota, for instance, the program Sources of Strength was developed for tribal communities to promote connectedness between youth and adults.

Related: Improving Veteran Engagement With Mental Health Care

The Health Resource and Service Administration (HRSA) also has developed activities to address suicide in rural areas, including epidemiologic studies, research, telemedicine, and programs addressing primary health care providers.

https://www.cdc.gov/violenceprevention/pub/technical-packages.html

https://www.hrsa.gov/ruralhealth

More than half a million people committed suicide between 2001 and 2015, according to the CDC. Rural counties consistently had higher rates than those of metropolitan areas. “While we’ve seen many causes of death come down in recent years, suicide rates have increased more than 20% from 2001 to 2015,” said Brenda Fitzgerald, MD, CDC director. “And this is especially concerning in rural areas.”

Related: Suicide Federal Health Data Trends

Suicide rates in rural counties were 17.32 per 100,000 people compared with 14.86 in small-to-medium metropolitan counties and 11.92 in large metropolitan counties. Rates for American Indian/Alaska Native non-Hispanics were the highest.

The researchers note that, at some points, different negative factors had more impact. For instance, rural communities were harder hit by housing foreclosures, poverty, and unemployment due to the recession. However, the researchers also point out that suicide rates were on the rise before the recession began.

“The trends in suicide rates…are magnified in rural areas,” said James Mercy, PhD, director of CDC’s Division of Violence Prevention. “This report underscores the need for suicide prevention strategies that are specifically tailored for these communities.” To that end, the CDC recently released a compilation of evidence-based strategies that have the greatest prevention potential. The set includes examples of programs that can be customized to fit the cultural needs of different groups. In North Dakota, for instance, the program Sources of Strength was developed for tribal communities to promote connectedness between youth and adults.

Related: Improving Veteran Engagement With Mental Health Care

The Health Resource and Service Administration (HRSA) also has developed activities to address suicide in rural areas, including epidemiologic studies, research, telemedicine, and programs addressing primary health care providers.

https://www.cdc.gov/violenceprevention/pub/technical-packages.html

https://www.hrsa.gov/ruralhealth

If you missed the recent headlines, Why Patients Delay Medical Payments: 12 findings ¹ and You think your health insurance costs too much. Try being a farmer.², you may not be too worried about your ever-rising accounts receivables. But you should be.

The facts in these stories and the 2017 Employer Health Benefits Survey,³ released on September 19 by the non-partisan Kaiser Family Foundation and Health Research & Educational Trust (HRET), are alarming. Let’s look at some of the survey results.

Since 2007, the average family premium has increased 55% and the average worker contribution toward the premium has increased 74%.³ How does that translate into dollars and cents? Well, the average annual premiums this year are $6690 for single coverage and $18,764 for family coverage.   

What does that mean exactly to the farm couple in the Crain’s story? The farmer who “will be lucky to net $75,000” on his hay crop this year has a policy premium with Blue Cross Blue Shield of Illinois that was $22,000 last year. And then there is a $5000 deductible for each him and his wife. Do the math: it means they’d spend 43% of their income before health insurance covers anything.   

Do premiums vary significantly by firm size or region? Should surgeons in certain areas of the country be less concerned about these trends? No, the premiums don’t significantly vary by size or region.  

The point here is not to write an essay about health insurance premiums, but rather to discuss what this economic reality means to patients who are seeing you tomorrow, next week, and next month. Given these economic realities, what is their attitude about your bill? 

For insight, let’s look at an Advisory Board Company brief, “Minimizing Bad Debt: Point-of-Service Collections,”⁴ which states: “Patient propensity to pay decreases as patient obligation increases.” According to the brief, “Our analysis indicates that as the dollar value of a patient’s obligation increases, their propensity to pay any portion of the obligation decreases—for all patients, at all income levels.” See Figure 1.

Given that market statistics show that more than a quarter of the commercially insured patients are covered by high deductible health plans (HDHPs), your practice must adapt to these changing times.

Review Your Pay or Mix

Smart practice administrators will keep their finger on the pulse of the insurance local market as more employers move toward offering HDHPs or health savings accounts. Knowing what the largest manufacturers are offering, along with local hospitals that are typically sizable employers in most communities, is critical. The coverage for school systems, police departments, fire departments, and governments should also be the practice radar. 

A recent West Corporation survey⁵ reveals more about the demographic profile of patients who are less likely to pay or delay payments. Their study shows that 79% of patients cite affordability as the largest healthcare problem with 93% of patients saying it costs too much. So it should be no surprise that 67% say their financial situation makes it challenging to submit timely payments. If you are not familiar with the company name, you’ll be familiar with West Corporation’s products, like Televox, which are automated tools used by practices to remind patients about appointments and copays.  

Here are other relevant findings from the West Corporation survey:

• 56% delay payments of medical bills at least some of the time. 
• 70% of millennials have missed medical payment deadlines. 
• 42% of patients cite their HDHP as the reason for delaying their payments. 
• 36% of patients said they have difficulty remembering to make timely medical payments.  

It’s no surprise that orthopedic surgeons are not discussing fees with patients. Although only 9% admitted that they don’t discuss costs with patients, it is safe to estimate that few surgeons have their fee schedules memorized. 

In a 2013 article, Ubel and colleagues⁷ said, “Because treatments can be ‘financially toxic,’ physicians need to disclose the financial consequences of treatment alternatives just as they inform patients about treatments’ side effects.” 

While uniquely qualified to discuss treatment options, few orthopedic surgeons have the time or the facts to personally discuss fees, out-of-pocket expenses, uncovered services and payment plans. Detailed discussions about patients’ financial liabilities are better done by qualified staff, who verify benefits and use modern technology tools to generate an electronic “estimate of costs and benefits.” 

What steps can your practice take to help patients pay their portion, even when it’s large, as well as help your practice reduce receivables and avoid collection problems and bad debt write-offs?

Start by analyzing the top Current Procedural Terminology (CPT) codes with patient responsibility, so you can focus your efforts. One such analysis, conducted by our firm, is shown in Figure 3. Although you might think the highest percent of patient financial responsibilities are for surgical procedures, notice that 4 of the top 5 services this practice identified as having the highest amount of patient collectible dollars are rendered in the office-carpal tunnel surgery being the only exception.

Take Action 

After conducting a thorough analysis and reviewing the results, here are 5 actionable steps your practice could take: 

1. Make sure your patient portal has the capacity to take patient payments. Offering online payment options increases the opportunity for patients to pay. Promote this option on the patient statement.  

2. Implement a system of collecting from patients before they leave the office. After a new visit, which involves a more expensive evaluation and management code, and possibly imaging and durable medical device, counsel patients to leave a credit card on file, so the minute insurance pays, their credit card can be charged. 

The 2017 Navicure Patient Payment Check-Up survey⁸ conducted by Healthcare Information and Management Systems Society (HIMSS) Analytics shows that 78% of patients would provide a card to be charged for one time up to $200. Think about the previously illustrated collection amounts this would alleviate.

3. Provide all surgery patients with a cost estimate. Generating cost estimates has been possible for close to 10 years. It’s done through your clearinghouse and practice management software by entering the CPT codes and diagnosis codes, along with the patient’s information. Save time and avoid tying staff up on hold. 

According to the Navicure Patient Payment Check-Up survey,⁸ 75% of provider organizations are able to provide a cost estimate upon request. It makes good business sense.

4. Collect a pre-treatment or pre-surgery scheduling deposit. In the KarenZupko & Associates/American Academy of Orthopaedic Surgeons (AAOS) pre-course survey of those attending the 2017 coding and reimbursement workshops, 55% of orthopedic practices reported that they have instituted such a practice. With the proliferation of HDHPs, asking for a scheduling deposit is fast becoming a must for all surgeons.

5. Offer patients a healthcare financing option through a third party. In response to another pre-course survey question, about offering CareCredit or another healthcare credit card, 28% of orthopedic practices say they do. Still, that leaves >70% of the orthopedic patients without a financing option. Given the reality of high deductible HDHPs and the patient responsibilities going uncollected, it’s time surgeons take a look at financing. It’s a fool’s wish to believe the practice is “saving” the service fee by sending dozens of statements, having staff make calls, and ultimately writing off unpaid balances as uncollectible.

Practices that fail to change, will fail to prosper. Those who have technology-phobic staff will suffer as healthcare continues to automate. Practices led by surgeons like one recently interviewed who said, “If patients knew how much it cost, they’d never schedule” will see patient accounts receivable soar and patient online ratings sink. The first quarter of 2018 means the number of patients with HDHPs will increase and that deductibles will have to be met. It’s wise to have a full staff meeting, share the facts, and put an action plan in place.

If you missed the recent headlines, Why Patients Delay Medical Payments: 12 findings ¹ and You think your health insurance costs too much. Try being a farmer.², you may not be too worried about your ever-rising accounts receivables. But you should be.

The facts in these stories and the 2017 Employer Health Benefits Survey,³ released on September 19 by the non-partisan Kaiser Family Foundation and Health Research & Educational Trust (HRET), are alarming. Let’s look at some of the survey results.

Since 2007, the average family premium has increased 55% and the average worker contribution toward the premium has increased 74%.³ How does that translate into dollars and cents? Well, the average annual premiums this year are $6690 for single coverage and $18,764 for family coverage.   

What does that mean exactly to the farm couple in the Crain’s story? The farmer who “will be lucky to net $75,000” on his hay crop this year has a policy premium with Blue Cross Blue Shield of Illinois that was $22,000 last year. And then there is a $5000 deductible for each him and his wife. Do the math: it means they’d spend 43% of their income before health insurance covers anything.   

Do premiums vary significantly by firm size or region? Should surgeons in certain areas of the country be less concerned about these trends? No, the premiums don’t significantly vary by size or region.  

The point here is not to write an essay about health insurance premiums, but rather to discuss what this economic reality means to patients who are seeing you tomorrow, next week, and next month. Given these economic realities, what is their attitude about your bill? 

For insight, let’s look at an Advisory Board Company brief, “Minimizing Bad Debt: Point-of-Service Collections,”⁴ which states: “Patient propensity to pay decreases as patient obligation increases.” According to the brief, “Our analysis indicates that as the dollar value of a patient’s obligation increases, their propensity to pay any portion of the obligation decreases—for all patients, at all income levels.” See Figure 1.

Given that market statistics show that more than a quarter of the commercially insured patients are covered by high deductible health plans (HDHPs), your practice must adapt to these changing times.

Review Your Pay or Mix

Smart practice administrators will keep their finger on the pulse of the insurance local market as more employers move toward offering HDHPs or health savings accounts. Knowing what the largest manufacturers are offering, along with local hospitals that are typically sizable employers in most communities, is critical. The coverage for school systems, police departments, fire departments, and governments should also be the practice radar. 

A recent West Corporation survey⁵ reveals more about the demographic profile of patients who are less likely to pay or delay payments. Their study shows that 79% of patients cite affordability as the largest healthcare problem with 93% of patients saying it costs too much. So it should be no surprise that 67% say their financial situation makes it challenging to submit timely payments. If you are not familiar with the company name, you’ll be familiar with West Corporation’s products, like Televox, which are automated tools used by practices to remind patients about appointments and copays.  

Here are other relevant findings from the West Corporation survey:

• 56% delay payments of medical bills at least some of the time. 
• 70% of millennials have missed medical payment deadlines. 
• 42% of patients cite their HDHP as the reason for delaying their payments. 
• 36% of patients said they have difficulty remembering to make timely medical payments.  

It’s no surprise that orthopedic surgeons are not discussing fees with patients. Although only 9% admitted that they don’t discuss costs with patients, it is safe to estimate that few surgeons have their fee schedules memorized. 

In a 2013 article, Ubel and colleagues⁷ said, “Because treatments can be ‘financially toxic,’ physicians need to disclose the financial consequences of treatment alternatives just as they inform patients about treatments’ side effects.” 

While uniquely qualified to discuss treatment options, few orthopedic surgeons have the time or the facts to personally discuss fees, out-of-pocket expenses, uncovered services and payment plans. Detailed discussions about patients’ financial liabilities are better done by qualified staff, who verify benefits and use modern technology tools to generate an electronic “estimate of costs and benefits.” 

What steps can your practice take to help patients pay their portion, even when it’s large, as well as help your practice reduce receivables and avoid collection problems and bad debt write-offs?

Start by analyzing the top Current Procedural Terminology (CPT) codes with patient responsibility, so you can focus your efforts. One such analysis, conducted by our firm, is shown in Figure 3. Although you might think the highest percent of patient financial responsibilities are for surgical procedures, notice that 4 of the top 5 services this practice identified as having the highest amount of patient collectible dollars are rendered in the office-carpal tunnel surgery being the only exception.

Take Action 

After conducting a thorough analysis and reviewing the results, here are 5 actionable steps your practice could take: 

1. Make sure your patient portal has the capacity to take patient payments. Offering online payment options increases the opportunity for patients to pay. Promote this option on the patient statement.  

2. Implement a system of collecting from patients before they leave the office. After a new visit, which involves a more expensive evaluation and management code, and possibly imaging and durable medical device, counsel patients to leave a credit card on file, so the minute insurance pays, their credit card can be charged. 

The 2017 Navicure Patient Payment Check-Up survey⁸ conducted by Healthcare Information and Management Systems Society (HIMSS) Analytics shows that 78% of patients would provide a card to be charged for one time up to $200. Think about the previously illustrated collection amounts this would alleviate.

3. Provide all surgery patients with a cost estimate. Generating cost estimates has been possible for close to 10 years. It’s done through your clearinghouse and practice management software by entering the CPT codes and diagnosis codes, along with the patient’s information. Save time and avoid tying staff up on hold. 

According to the Navicure Patient Payment Check-Up survey,⁸ 75% of provider organizations are able to provide a cost estimate upon request. It makes good business sense.

4. Collect a pre-treatment or pre-surgery scheduling deposit. In the KarenZupko & Associates/American Academy of Orthopaedic Surgeons (AAOS) pre-course survey of those attending the 2017 coding and reimbursement workshops, 55% of orthopedic practices reported that they have instituted such a practice. With the proliferation of HDHPs, asking for a scheduling deposit is fast becoming a must for all surgeons.

5. Offer patients a healthcare financing option through a third party. In response to another pre-course survey question, about offering CareCredit or another healthcare credit card, 28% of orthopedic practices say they do. Still, that leaves >70% of the orthopedic patients without a financing option. Given the reality of high deductible HDHPs and the patient responsibilities going uncollected, it’s time surgeons take a look at financing. It’s a fool’s wish to believe the practice is “saving” the service fee by sending dozens of statements, having staff make calls, and ultimately writing off unpaid balances as uncollectible.

Practices that fail to change, will fail to prosper. Those who have technology-phobic staff will suffer as healthcare continues to automate. Practices led by surgeons like one recently interviewed who said, “If patients knew how much it cost, they’d never schedule” will see patient accounts receivable soar and patient online ratings sink. The first quarter of 2018 means the number of patients with HDHPs will increase and that deductibles will have to be met. It’s wise to have a full staff meeting, share the facts, and put an action plan in place.

If you missed the recent headlines, Why Patients Delay Medical Payments: 12 findings ¹ and You think your health insurance costs too much. Try being a farmer.², you may not be too worried about your ever-rising accounts receivables. But you should be.

The facts in these stories and the 2017 Employer Health Benefits Survey,³ released on September 19 by the non-partisan Kaiser Family Foundation and Health Research & Educational Trust (HRET), are alarming. Let’s look at some of the survey results.

Since 2007, the average family premium has increased 55% and the average worker contribution toward the premium has increased 74%.³ How does that translate into dollars and cents? Well, the average annual premiums this year are $6690 for single coverage and $18,764 for family coverage.   

What does that mean exactly to the farm couple in the Crain’s story? The farmer who “will be lucky to net $75,000” on his hay crop this year has a policy premium with Blue Cross Blue Shield of Illinois that was $22,000 last year. And then there is a $5000 deductible for each him and his wife. Do the math: it means they’d spend 43% of their income before health insurance covers anything.   

Do premiums vary significantly by firm size or region? Should surgeons in certain areas of the country be less concerned about these trends? No, the premiums don’t significantly vary by size or region.  

The point here is not to write an essay about health insurance premiums, but rather to discuss what this economic reality means to patients who are seeing you tomorrow, next week, and next month. Given these economic realities, what is their attitude about your bill? 

For insight, let’s look at an Advisory Board Company brief, “Minimizing Bad Debt: Point-of-Service Collections,”⁴ which states: “Patient propensity to pay decreases as patient obligation increases.” According to the brief, “Our analysis indicates that as the dollar value of a patient’s obligation increases, their propensity to pay any portion of the obligation decreases—for all patients, at all income levels.” See Figure 1.

Given that market statistics show that more than a quarter of the commercially insured patients are covered by high deductible health plans (HDHPs), your practice must adapt to these changing times.

Review Your Pay or Mix

Smart practice administrators will keep their finger on the pulse of the insurance local market as more employers move toward offering HDHPs or health savings accounts. Knowing what the largest manufacturers are offering, along with local hospitals that are typically sizable employers in most communities, is critical. The coverage for school systems, police departments, fire departments, and governments should also be the practice radar. 

A recent West Corporation survey⁵ reveals more about the demographic profile of patients who are less likely to pay or delay payments. Their study shows that 79% of patients cite affordability as the largest healthcare problem with 93% of patients saying it costs too much. So it should be no surprise that 67% say their financial situation makes it challenging to submit timely payments. If you are not familiar with the company name, you’ll be familiar with West Corporation’s products, like Televox, which are automated tools used by practices to remind patients about appointments and copays.  

Here are other relevant findings from the West Corporation survey:

• 56% delay payments of medical bills at least some of the time. 
• 70% of millennials have missed medical payment deadlines. 
• 42% of patients cite their HDHP as the reason for delaying their payments. 
• 36% of patients said they have difficulty remembering to make timely medical payments.  

It’s no surprise that orthopedic surgeons are not discussing fees with patients. Although only 9% admitted that they don’t discuss costs with patients, it is safe to estimate that few surgeons have their fee schedules memorized. 

In a 2013 article, Ubel and colleagues⁷ said, “Because treatments can be ‘financially toxic,’ physicians need to disclose the financial consequences of treatment alternatives just as they inform patients about treatments’ side effects.” 

While uniquely qualified to discuss treatment options, few orthopedic surgeons have the time or the facts to personally discuss fees, out-of-pocket expenses, uncovered services and payment plans. Detailed discussions about patients’ financial liabilities are better done by qualified staff, who verify benefits and use modern technology tools to generate an electronic “estimate of costs and benefits.” 

What steps can your practice take to help patients pay their portion, even when it’s large, as well as help your practice reduce receivables and avoid collection problems and bad debt write-offs?

Start by analyzing the top Current Procedural Terminology (CPT) codes with patient responsibility, so you can focus your efforts. One such analysis, conducted by our firm, is shown in Figure 3. Although you might think the highest percent of patient financial responsibilities are for surgical procedures, notice that 4 of the top 5 services this practice identified as having the highest amount of patient collectible dollars are rendered in the office-carpal tunnel surgery being the only exception.

Take Action 

After conducting a thorough analysis and reviewing the results, here are 5 actionable steps your practice could take: 

1. Make sure your patient portal has the capacity to take patient payments. Offering online payment options increases the opportunity for patients to pay. Promote this option on the patient statement.  

2. Implement a system of collecting from patients before they leave the office. After a new visit, which involves a more expensive evaluation and management code, and possibly imaging and durable medical device, counsel patients to leave a credit card on file, so the minute insurance pays, their credit card can be charged. 

The 2017 Navicure Patient Payment Check-Up survey⁸ conducted by Healthcare Information and Management Systems Society (HIMSS) Analytics shows that 78% of patients would provide a card to be charged for one time up to $200. Think about the previously illustrated collection amounts this would alleviate.

3. Provide all surgery patients with a cost estimate. Generating cost estimates has been possible for close to 10 years. It’s done through your clearinghouse and practice management software by entering the CPT codes and diagnosis codes, along with the patient’s information. Save time and avoid tying staff up on hold. 

According to the Navicure Patient Payment Check-Up survey,⁸ 75% of provider organizations are able to provide a cost estimate upon request. It makes good business sense.

4. Collect a pre-treatment or pre-surgery scheduling deposit. In the KarenZupko & Associates/American Academy of Orthopaedic Surgeons (AAOS) pre-course survey of those attending the 2017 coding and reimbursement workshops, 55% of orthopedic practices reported that they have instituted such a practice. With the proliferation of HDHPs, asking for a scheduling deposit is fast becoming a must for all surgeons.

5. Offer patients a healthcare financing option through a third party. In response to another pre-course survey question, about offering CareCredit or another healthcare credit card, 28% of orthopedic practices say they do. Still, that leaves >70% of the orthopedic patients without a financing option. Given the reality of high deductible HDHPs and the patient responsibilities going uncollected, it’s time surgeons take a look at financing. It’s a fool’s wish to believe the practice is “saving” the service fee by sending dozens of statements, having staff make calls, and ultimately writing off unpaid balances as uncollectible.

Practices that fail to change, will fail to prosper. Those who have technology-phobic staff will suffer as healthcare continues to automate. Practices led by surgeons like one recently interviewed who said, “If patients knew how much it cost, they’d never schedule” will see patient accounts receivable soar and patient online ratings sink. The first quarter of 2018 means the number of patients with HDHPs will increase and that deductibles will have to be met. It’s wise to have a full staff meeting, share the facts, and put an action plan in place.

Take-Home Points

• Patella alta has a reduced articular area of PF contact.
• Presence of patella alta depends on the measurement method.
• Patella alta is defined as ISI >1.2 and CDI >1.2 to >1.3.
• On sagittal MRI, PTI is used most often with cutoff values of <0.125 to 0.28.
• Tibial tubercle distalization is most often used to treat patella alta. The desired postoperative patellar height is a CDI of 1.0.

Patella alta is a patella that rides abnormally high in relation to the femur, the femoral trochlea, or the tibia,¹ with decreased bony stability requiring increased knee flexion angles to engage the trochlea.^2,3 An abnormally high patella may therefore insufficiently engage the proximal trochlea groove both in extension and in the early phase of knee flexion—making it one of the potential risk factors for patellar instability.^4-10 Accordingly, patella alta is present in 30% of patients with recurrent patellar dislocation.¹¹ It also occurs in other disorders, such as knee extensor apparatus disorders, in patients with patellofemoral (PF) pain, chondromalacia, Sinding-Larsen-Johansson disease, Osgood-Schlatter disease, patellar tendinopathy, and osteoarthritis.^1,7,8,12-18 As such, patella alta represents an important predisposing factor for patellar malalignment and PF-related complaints. On the other hand, patella alta may also be a normal variant of a person’s knee anatomy and may be well tolerated when not combined with other instability factors.⁴

Despite the importance of patella alta, there is no consensus on a precise definition, the most reliable measurement method, or the factors thought to be important in clinical decisions regarding treatment. To address this issue, we systematically reviewed the patella alta literature for definitions, the most common measurement methods and their patella alta cutoff values, and cutoff values for surgical correction and proposed surgical techniques.

Methods

In February 2017, using the term patella alta, we performed a systematic literature search on PubMed. Inclusion criteria were original study or review articles, publication in peer-reviewed English-language journals between 2000 and 2017, and narrative description or measurement of human patellar height on plain radiographs or magnetic resonance imaging (MRI). Excluded were abstracts and articles in languages other than English; animal and computational/biomechanical studies; case reports; and knee arthroplasties, knee extensor ruptures, and hereditary and congenital diseases. All evidence levels were included.

We assessed measurement methods, reported cutoff values for patella alta, cutoff values for performing surgical correction, proposed surgical techniques, and postoperative target values. Original study articles and review articles were analyzed separately.

Results

Of 211 articles identified, 92 met the inclusion criteria for original study, and 28 for review. All their abstracts were reviewed, and 91 were excluded: 17 for language other than English, 11 for animal study, 12 for biomechanical/computational study, 20 for case report, 8 for arthroplasty, 13 for hereditary or congenital disease, 1 for extensor apparatus rupture, 3 for editorial letter, and 6 for other reasons. Full text copies of all included articles were obtained and reviewed.

Original Study Articles

Definition. Of the 92 original study articles, 17 (18.5%) defined patella alta by description alone, and 75 (81.5%) used imaging-based measurements. Patella alta was described as a patella that rides abnormally high in relation to the trochlear groove, with a reduced articular area of PF contact^1,15,19-21 or decreased patella–trochlea cartilage overlap.²² With this reduced contact area, there is increased PF stress.²¹

With radiographic measurements, patella alta is defined as a Caton-Deschamps index (CDI) of >1.2 to >1.3, an Insall-Salvati index (ISI) of >1.2, a Blackburne-Peel index (PBI) of >1.0,^{4,15,18,23-25} and a patellotrochlear index (PTI) of <0.125 to 0.28.^6,26

On lateral radiographs, ISI was the most common measurement (33 studies), with patella alta cutoff values ranging from >1.2 to >1.5. The second most common measurement was CDI (24 studies), with cutoff values of >1.2 to >1.3. Other indices, such as the modified ISI (6 studies), the BPI (1 study), and the Koshino index (2 studies), had their cutoff values used more consistently (>1.6 to >2.4, >1.0, and >1.2, respectively) but these indices were rarely reported in the literature (Table 1).^27,28,29 

Thirty-six studies defined patella alta with MRI using either the aforementioned radiographic ratios (23 studies, 3 indices, Table 2) or PF indices (13 studies, 4 methods, Table 3).³⁰ 

On sagittal MRI, PTI was used most often; cutoff values were <0.125 to 0.28.

Thirteen studies defined patella alta with PTL: 5 using lateral conventional radiographs and 8 using sagittal MRI. For each type of imaging, the cutoff value was >52 mm to >56 mm. PTL was measured either independently or together with ISI on sagittal MRI (Table 4).

22

Review Articles

Twenty-eight review articles met the inclusion criteria.^35-40 Patella alta was described mostly with ISI (75%) or CDI (64%). In up to 57% of these articles, a patella alta reference value was missing. Only 1 article mentioned different cutoff values for conventional radiographs and MRI. BPI was mentioned in 50% of studies, but only 2 indicated a cutoff value for patella alta. Eleven percent used PTI on sagittal MRI and took patella–trochlea cartilage overlap into account.

Eight review articles mentioned cutoff values for surgical correction. Only 1 of 4 articles mentioned a cutoff value for correcting patella alta in PF instability, and only 2 articles suggested an ideal postoperative patellar height (Table 6).

No review article relied on PTL to describe patella alta or to advise surgical treatment.

Discussion 

Our review revealed many variations in patella alta definitions and descriptions, measurement methods, cutoff values, and treatment options. Interpretation of patellar height and, particularly, patella alta is very heterogeneous. Accordingly, comparing surgical indications, surgical treatment options, and outcomes across studies can be difficult.

Measurement Methods

Radiographs. Conventional radiographs were used to describe patella alta in two-thirds of the original study articles. The most common measurement methods marked the position of the patella relative to either the femur (direct assessment) or the tibia (indirect assessment).^14,25 All established measurement methods use lateral radiographs, which do not show articular cartilage.^11,14 Therefore, lateral radiograph ratios of different and variable bony landmarks do not measure actual PF articular congruence. The widely variable morphologies of patella (distal patellar nose, different articulating surface), femoral trochlea (facet in height and length), proximal tibia (inherited or acquired deformities on tibial tubercle), and slope are all confounding factors that may affect measurement (Figure 1). In addition, specific variations in PF joint morphology (eg, small patellar articular surface, short trochlea) are not well represented by these ratios.¹¹

All these methods have advantages, limitations, and different values of interobserver and intraobserver variability, reliability, and reproducibility (Table 7).^29,41

Determination of both patellar height and patella alta depends on the measurement method used and is significantly affected by anatomical variants, such as extra-articular patella and femorotibial landmarks. 

The ISI method is most commonly used because it does not depend on degree of knee flexion, is thought to measure the relative length of the patellar tendon the best,⁵ and has established MRI criteria.⁶ However, ISI has limitations: Its distal bony landmark is the tibial tuberosity, which can be difficult to assess¹⁴; the shape of the patella (mainly its inferior point) varies⁴²; and the measurement does not change after distalization of the tibial tubercle.⁵

CDI is the most accurate diagnostic method because it relies on readily identifiable and reproducible anatomical landmarks; does not depend on radiograph quality, knee size, radiologic enlargement, or position of the tibial tubercle or patellar modification; and is unaffected by degree of knee flexion between 10° and 80°.^38,43 CDI is the method that is most useful in describing patellar height after distalization of the tibial tubercle because it assesses the height of the patella relative to the tibial plateau.⁵ CDI is limited with respect to clear identification of the patellar and tibial articular margin.³⁷

BPI has the lowest interobserver variability and discriminates best among patella alta, norma, and infera.⁴¹ Like CDI, BPI assesses patellar height relative to the tibial plateau, and thus is useful in describing patellar height after distalization of the tibial tubercle.⁵ BPI is limited in that it uses a line drawn along the tibial plateau, where variations in inclination and tibial slope produce inaccuracies,¹⁴ and depends highly on projection angles. Clinically, BPI is rarely used.

As the literature shows, the radiologic methods of determining patellar height are variable and unreliable and depend on the ratio used.^26,41 These methods do not reveal precise information about the PF articular congruence, the key finding for necessary treatment.

Radiographic Indices on MRI. Some studies measured radiographic indices on sagittal MRI. Radiologic and MRI measurements are described as not significantly different or slightly different, and 0.09 to 0.13 needs to be added with ISI and BP ratios on radiographs, MRI, and computed tomography (CT).^17,44-47 ISI is commonly used, and its clinical application is easy. Although classically measured on plain radiographs, ISI is reliably measured on MRI as well.^17,30 The traditional 1.2 threshold for defining patella alta was used by Charles and colleagues.⁴⁴ CDI is equally well measured on radiographs and MRI.⁴⁷

According to the literature, 3 different measurement methods have been used to describe degree of patella–trochlea cartilage overlap: PTI, sagittal patellofemoral engagement (SPE), and patellar articular overlap (PAO).^1,11,26

PTI uses the true articular cartilage patella–trochlea relationship for measurement of patellar height on sagittal MRI in extension (Figure 3). If the patellar tendon is fully out to length (no laxity), PTI reliably and precisely determines the exact articular correlation of PF joint and patellar height.⁶

SPE is similar to percentage of articular coverage.^1,11 Patellar overlap of the trochlea is measured on 2 different sagittal MRI images: 1 with the greatest length of patellar cartilage and 1 with the greatest length of femoral trochlear cartilage. This measurement did not correlate with CDI.¹ SPE was not evaluated in control studies, and normal and pathologic values are unavailable.

PAO is measured with patients positioned at rest and in standard knee coils.¹ MRI was not obtained in full extension or with quadriceps activation, and knee flexion angle values are unavailable. Total patellar articular length was measured on the sagittal MRI that showed the greatest patellar length and articular cartilage thickness. The same image was used to measure articular overlap, or the length of patellar cartilage overlying the trochlear cartilage, as measured parallel to the subchondral surface of the patella. PAO correlates well with conventional patellar height measurements in the sagittal plane and shows promise as a simpler alternative to the conventional indices.¹ Normal and pathologic values are unavailable.

So far, PTI is the only method that was controlled in several studies, assessed for its reliability, and compared with other patellar height measurements.^6,14

Patellar Tendon Length. PTL can be measured on lateral radiographs or sagittal MRI. Radiologic and MRI measurements are described as not significantly different⁴⁷ or slightly different, and 0.09 to 0.13 needs to be added with the ISI ratio on radiographs, MRI, and CT.⁴⁶ PTL is reliably evaluated with ISI.^41,50 There is a weak correlation of patient height and PTL: Taller people have normally longer tendons.^51-53

PTL measurements revealed that the posterior surface of the patellar tendon was significantly shorter than the anterior surface. Compared with their corresponding posterior fascicles, anterior fascicles are longer; their attachment is more proximal to the patella and more distal to the tibia. In addition, posterior PTL is significantly shorter with the posterior patellar attachment (adheres to posterior aspect of the inferior patellar pole) than with the anterior attachment (adheres to anterior aspect of the inferior patellar pole).⁵⁶ Moreover, the lateral and medial fascicles are longer than the central fascicles attaching at the most inferior patellar pole. This issue must be considered in image cut selection (Figures 6A, 6B). Furthermore, type of inferior pole of patella (pointed, intermediate, blunt) is important in measurement.⁵⁶ Overall, mean (SD) PTL was 54.9 (1.2) mm on the anterior surface and 35.0 (0.6) mm on the posterior surface.

It is important to precisely describe the measurement method and location (sagittal cut) and to consider the shape of the inferior patellar pole and the site of the patellar tendon attachment.⁵⁶

Treatments. For patella alta, the surgical treatment goals are to increase the PF contact area and improve PF articular congruence, and thereby increase PF stability.^31-33 Four different procedures were used to treat patella alta (Table 5), but only 11 of the 92 original study articles and 8 of the 28 review articles included in our review mentioned a specific patellar height that required surgical correction (Tables 5, 6). Recommendations were based on CDI (>1.2 to >1.4) and less often on ISI (>1.2 to >1.4) or PTL (>56 mm).

Tibial tubercle distalization is effective in normalizing patellar height to correct the patellar index in patella alta (Figures 7A, 7B).^{13,18,38,55,57} Tibial tubercle distalization and patellar tendon tenodesis attached to the original insertion normalize PTL and stabilize the PF joint in patients with patella alta.^5,47 In a comparison of these surgical procedures, cartilage stress was lower with distalization than with distalization and tenodesis.¹³

Soft-tissue methods are recommended in children, as bone procedures injure the proximal tibial physis and may cause it to close prematurely.⁵⁸ The patella can be distally advanced by completely mobilizing the patellar tendon and fixating with sutures through the cartilaginous tibial tubercle. This technique is a satisfactory treatment for skeletally immature patients who present with habitual patellar dislocation associated with patella alta.^58,59

CDI and BPI assess patellar height relative to the tibial plateau, and therefore are the most useful measurement methods for patellar height after distalization of the tibial tubercle.⁵ ISI does not change after distalization of the tibial tubercle and cannot be recommended.^5,18 As PF indices (eg, PTI) can trace preoperative and postoperative values, these measurements are valuable.

Controversies

Our review found no consensus on measurement method or cutoff value. No measurement method showed clear clinical or methodologic superiority. Most published patellar height and patella alta data are based on conventional radiographs using a tibial reference point, even though a femoral or even trochlear reference point seems more reproducible, particularly in PF pathologies. Several cutoff values have been reported for each patella alta measurement method. Regarding pathologic thresholds, which might require surgical correction, very little information has been published, and scientific evidence is lacking. Numerous important aspects remain unanswered after this review, and clarification is mandatory.

Five Key Facts

1. In patella alta assessment, different morphologic, biomechanical, and functional aspects must be considered. The most relevant aspect is decreased engagement of the patella and trochlea,^4-9,11,26 which results in decreased bony stability in knee extension.^1-3 Therefore, patella alta is one of the potential risk factors for patellar instability with a high percentage of recurrent patellar dislocation.^4-9 In early knee flexion, the patella translates more distally with better engagement of the patella in the trochlea and better stability. Therefore, measurement in extension, with the patellar tendon out to length, seems to offer a more reliable assessment of the patella–femur relationship.

2. Insufficient engagement of the patella in the trochlea is the most important aspect of patella alta.¹¹ Therefore, direct measurement of this engagement seems logical.

3. As radiographs do not show articular cartilage, they should not be used to assess the articular patella–femur relationship.^11,14,26 Patella–trochlea cartilage overlap is the most relevant factor for patella alta and should be measured on MRI.^6,14,26,32

4. PTL is an important factor for patellar height and particularly patella alta. The range of normal PTL values is wide: 35 mm to 61 mm. The described cutoff values for patella alta (>52 mm to >56 mm) fall within this normal range. The cause may be the different measurement methods used.^33,47,59-61 Therefore, for precise diagnostics, a standardized measurement method that includes the selected cut imaging is mandatory.

Conclusion 

Our review revealed many variations in patella alta definitions and descriptions, measurement methods, cutoff values, and treatment options. Presence of patella alta depends on measurement method used. Methods cannot be used interchangeably, and they all have their advantages and limitations. Unfortunately, there is no generally accepted consensus on measurement method, patella alta cutoff value, or treatment with ideal correction. Treatment planning and outcomes assessment require clarification of these many issues.

Take-Home Points

• Patella alta has a reduced articular area of PF contact.
• Presence of patella alta depends on the measurement method.
• Patella alta is defined as ISI >1.2 and CDI >1.2 to >1.3.
• On sagittal MRI, PTI is used most often with cutoff values of <0.125 to 0.28.
• Tibial tubercle distalization is most often used to treat patella alta. The desired postoperative patellar height is a CDI of 1.0.

Patella alta is a patella that rides abnormally high in relation to the femur, the femoral trochlea, or the tibia,¹ with decreased bony stability requiring increased knee flexion angles to engage the trochlea.^2,3 An abnormally high patella may therefore insufficiently engage the proximal trochlea groove both in extension and in the early phase of knee flexion—making it one of the potential risk factors for patellar instability.^4-10 Accordingly, patella alta is present in 30% of patients with recurrent patellar dislocation.¹¹ It also occurs in other disorders, such as knee extensor apparatus disorders, in patients with patellofemoral (PF) pain, chondromalacia, Sinding-Larsen-Johansson disease, Osgood-Schlatter disease, patellar tendinopathy, and osteoarthritis.^1,7,8,12-18 As such, patella alta represents an important predisposing factor for patellar malalignment and PF-related complaints. On the other hand, patella alta may also be a normal variant of a person’s knee anatomy and may be well tolerated when not combined with other instability factors.⁴

Despite the importance of patella alta, there is no consensus on a precise definition, the most reliable measurement method, or the factors thought to be important in clinical decisions regarding treatment. To address this issue, we systematically reviewed the patella alta literature for definitions, the most common measurement methods and their patella alta cutoff values, and cutoff values for surgical correction and proposed surgical techniques.

Methods

In February 2017, using the term patella alta, we performed a systematic literature search on PubMed. Inclusion criteria were original study or review articles, publication in peer-reviewed English-language journals between 2000 and 2017, and narrative description or measurement of human patellar height on plain radiographs or magnetic resonance imaging (MRI). Excluded were abstracts and articles in languages other than English; animal and computational/biomechanical studies; case reports; and knee arthroplasties, knee extensor ruptures, and hereditary and congenital diseases. All evidence levels were included.

We assessed measurement methods, reported cutoff values for patella alta, cutoff values for performing surgical correction, proposed surgical techniques, and postoperative target values. Original study articles and review articles were analyzed separately.

Results

Of 211 articles identified, 92 met the inclusion criteria for original study, and 28 for review. All their abstracts were reviewed, and 91 were excluded: 17 for language other than English, 11 for animal study, 12 for biomechanical/computational study, 20 for case report, 8 for arthroplasty, 13 for hereditary or congenital disease, 1 for extensor apparatus rupture, 3 for editorial letter, and 6 for other reasons. Full text copies of all included articles were obtained and reviewed.

Original Study Articles

Definition. Of the 92 original study articles, 17 (18.5%) defined patella alta by description alone, and 75 (81.5%) used imaging-based measurements. Patella alta was described as a patella that rides abnormally high in relation to the trochlear groove, with a reduced articular area of PF contact^1,15,19-21 or decreased patella–trochlea cartilage overlap.²² With this reduced contact area, there is increased PF stress.²¹

With radiographic measurements, patella alta is defined as a Caton-Deschamps index (CDI) of >1.2 to >1.3, an Insall-Salvati index (ISI) of >1.2, a Blackburne-Peel index (PBI) of >1.0,^{4,15,18,23-25} and a patellotrochlear index (PTI) of <0.125 to 0.28.^6,26

On lateral radiographs, ISI was the most common measurement (33 studies), with patella alta cutoff values ranging from >1.2 to >1.5. The second most common measurement was CDI (24 studies), with cutoff values of >1.2 to >1.3. Other indices, such as the modified ISI (6 studies), the BPI (1 study), and the Koshino index (2 studies), had their cutoff values used more consistently (>1.6 to >2.4, >1.0, and >1.2, respectively) but these indices were rarely reported in the literature (Table 1).^27,28,29 

Thirty-six studies defined patella alta with MRI using either the aforementioned radiographic ratios (23 studies, 3 indices, Table 2) or PF indices (13 studies, 4 methods, Table 3).³⁰ 

On sagittal MRI, PTI was used most often; cutoff values were <0.125 to 0.28.

Thirteen studies defined patella alta with PTL: 5 using lateral conventional radiographs and 8 using sagittal MRI. For each type of imaging, the cutoff value was >52 mm to >56 mm. PTL was measured either independently or together with ISI on sagittal MRI (Table 4).

22

Review Articles

Twenty-eight review articles met the inclusion criteria.^35-40 Patella alta was described mostly with ISI (75%) or CDI (64%). In up to 57% of these articles, a patella alta reference value was missing. Only 1 article mentioned different cutoff values for conventional radiographs and MRI. BPI was mentioned in 50% of studies, but only 2 indicated a cutoff value for patella alta. Eleven percent used PTI on sagittal MRI and took patella–trochlea cartilage overlap into account.

Eight review articles mentioned cutoff values for surgical correction. Only 1 of 4 articles mentioned a cutoff value for correcting patella alta in PF instability, and only 2 articles suggested an ideal postoperative patellar height (Table 6).

No review article relied on PTL to describe patella alta or to advise surgical treatment.

Discussion 

Our review revealed many variations in patella alta definitions and descriptions, measurement methods, cutoff values, and treatment options. Interpretation of patellar height and, particularly, patella alta is very heterogeneous. Accordingly, comparing surgical indications, surgical treatment options, and outcomes across studies can be difficult.

Measurement Methods

Radiographs. Conventional radiographs were used to describe patella alta in two-thirds of the original study articles. The most common measurement methods marked the position of the patella relative to either the femur (direct assessment) or the tibia (indirect assessment).^14,25 All established measurement methods use lateral radiographs, which do not show articular cartilage.^11,14 Therefore, lateral radiograph ratios of different and variable bony landmarks do not measure actual PF articular congruence. The widely variable morphologies of patella (distal patellar nose, different articulating surface), femoral trochlea (facet in height and length), proximal tibia (inherited or acquired deformities on tibial tubercle), and slope are all confounding factors that may affect measurement (Figure 1). In addition, specific variations in PF joint morphology (eg, small patellar articular surface, short trochlea) are not well represented by these ratios.¹¹

All these methods have advantages, limitations, and different values of interobserver and intraobserver variability, reliability, and reproducibility (Table 7).^29,41

Determination of both patellar height and patella alta depends on the measurement method used and is significantly affected by anatomical variants, such as extra-articular patella and femorotibial landmarks. 

The ISI method is most commonly used because it does not depend on degree of knee flexion, is thought to measure the relative length of the patellar tendon the best,⁵ and has established MRI criteria.⁶ However, ISI has limitations: Its distal bony landmark is the tibial tuberosity, which can be difficult to assess¹⁴; the shape of the patella (mainly its inferior point) varies⁴²; and the measurement does not change after distalization of the tibial tubercle.⁵

CDI is the most accurate diagnostic method because it relies on readily identifiable and reproducible anatomical landmarks; does not depend on radiograph quality, knee size, radiologic enlargement, or position of the tibial tubercle or patellar modification; and is unaffected by degree of knee flexion between 10° and 80°.^38,43 CDI is the method that is most useful in describing patellar height after distalization of the tibial tubercle because it assesses the height of the patella relative to the tibial plateau.⁵ CDI is limited with respect to clear identification of the patellar and tibial articular margin.³⁷

BPI has the lowest interobserver variability and discriminates best among patella alta, norma, and infera.⁴¹ Like CDI, BPI assesses patellar height relative to the tibial plateau, and thus is useful in describing patellar height after distalization of the tibial tubercle.⁵ BPI is limited in that it uses a line drawn along the tibial plateau, where variations in inclination and tibial slope produce inaccuracies,¹⁴ and depends highly on projection angles. Clinically, BPI is rarely used.

As the literature shows, the radiologic methods of determining patellar height are variable and unreliable and depend on the ratio used.^26,41 These methods do not reveal precise information about the PF articular congruence, the key finding for necessary treatment.

Radiographic Indices on MRI. Some studies measured radiographic indices on sagittal MRI. Radiologic and MRI measurements are described as not significantly different or slightly different, and 0.09 to 0.13 needs to be added with ISI and BP ratios on radiographs, MRI, and computed tomography (CT).^17,44-47 ISI is commonly used, and its clinical application is easy. Although classically measured on plain radiographs, ISI is reliably measured on MRI as well.^17,30 The traditional 1.2 threshold for defining patella alta was used by Charles and colleagues.⁴⁴ CDI is equally well measured on radiographs and MRI.⁴⁷

According to the literature, 3 different measurement methods have been used to describe degree of patella–trochlea cartilage overlap: PTI, sagittal patellofemoral engagement (SPE), and patellar articular overlap (PAO).^1,11,26

PTI uses the true articular cartilage patella–trochlea relationship for measurement of patellar height on sagittal MRI in extension (Figure 3). If the patellar tendon is fully out to length (no laxity), PTI reliably and precisely determines the exact articular correlation of PF joint and patellar height.⁶

SPE is similar to percentage of articular coverage.^1,11 Patellar overlap of the trochlea is measured on 2 different sagittal MRI images: 1 with the greatest length of patellar cartilage and 1 with the greatest length of femoral trochlear cartilage. This measurement did not correlate with CDI.¹ SPE was not evaluated in control studies, and normal and pathologic values are unavailable.

PAO is measured with patients positioned at rest and in standard knee coils.¹ MRI was not obtained in full extension or with quadriceps activation, and knee flexion angle values are unavailable. Total patellar articular length was measured on the sagittal MRI that showed the greatest patellar length and articular cartilage thickness. The same image was used to measure articular overlap, or the length of patellar cartilage overlying the trochlear cartilage, as measured parallel to the subchondral surface of the patella. PAO correlates well with conventional patellar height measurements in the sagittal plane and shows promise as a simpler alternative to the conventional indices.¹ Normal and pathologic values are unavailable.

So far, PTI is the only method that was controlled in several studies, assessed for its reliability, and compared with other patellar height measurements.^6,14

Patellar Tendon Length. PTL can be measured on lateral radiographs or sagittal MRI. Radiologic and MRI measurements are described as not significantly different⁴⁷ or slightly different, and 0.09 to 0.13 needs to be added with the ISI ratio on radiographs, MRI, and CT.⁴⁶ PTL is reliably evaluated with ISI.^41,50 There is a weak correlation of patient height and PTL: Taller people have normally longer tendons.^51-53

PTL measurements revealed that the posterior surface of the patellar tendon was significantly shorter than the anterior surface. Compared with their corresponding posterior fascicles, anterior fascicles are longer; their attachment is more proximal to the patella and more distal to the tibia. In addition, posterior PTL is significantly shorter with the posterior patellar attachment (adheres to posterior aspect of the inferior patellar pole) than with the anterior attachment (adheres to anterior aspect of the inferior patellar pole).⁵⁶ Moreover, the lateral and medial fascicles are longer than the central fascicles attaching at the most inferior patellar pole. This issue must be considered in image cut selection (Figures 6A, 6B). Furthermore, type of inferior pole of patella (pointed, intermediate, blunt) is important in measurement.⁵⁶ Overall, mean (SD) PTL was 54.9 (1.2) mm on the anterior surface and 35.0 (0.6) mm on the posterior surface.

It is important to precisely describe the measurement method and location (sagittal cut) and to consider the shape of the inferior patellar pole and the site of the patellar tendon attachment.⁵⁶

Treatments. For patella alta, the surgical treatment goals are to increase the PF contact area and improve PF articular congruence, and thereby increase PF stability.^31-33 Four different procedures were used to treat patella alta (Table 5), but only 11 of the 92 original study articles and 8 of the 28 review articles included in our review mentioned a specific patellar height that required surgical correction (Tables 5, 6). Recommendations were based on CDI (>1.2 to >1.4) and less often on ISI (>1.2 to >1.4) or PTL (>56 mm).

Tibial tubercle distalization is effective in normalizing patellar height to correct the patellar index in patella alta (Figures 7A, 7B).^{13,18,38,55,57} Tibial tubercle distalization and patellar tendon tenodesis attached to the original insertion normalize PTL and stabilize the PF joint in patients with patella alta.^5,47 In a comparison of these surgical procedures, cartilage stress was lower with distalization than with distalization and tenodesis.¹³

Soft-tissue methods are recommended in children, as bone procedures injure the proximal tibial physis and may cause it to close prematurely.⁵⁸ The patella can be distally advanced by completely mobilizing the patellar tendon and fixating with sutures through the cartilaginous tibial tubercle. This technique is a satisfactory treatment for skeletally immature patients who present with habitual patellar dislocation associated with patella alta.^58,59

CDI and BPI assess patellar height relative to the tibial plateau, and therefore are the most useful measurement methods for patellar height after distalization of the tibial tubercle.⁵ ISI does not change after distalization of the tibial tubercle and cannot be recommended.^5,18 As PF indices (eg, PTI) can trace preoperative and postoperative values, these measurements are valuable.

Controversies

Our review found no consensus on measurement method or cutoff value. No measurement method showed clear clinical or methodologic superiority. Most published patellar height and patella alta data are based on conventional radiographs using a tibial reference point, even though a femoral or even trochlear reference point seems more reproducible, particularly in PF pathologies. Several cutoff values have been reported for each patella alta measurement method. Regarding pathologic thresholds, which might require surgical correction, very little information has been published, and scientific evidence is lacking. Numerous important aspects remain unanswered after this review, and clarification is mandatory.

Five Key Facts

1. In patella alta assessment, different morphologic, biomechanical, and functional aspects must be considered. The most relevant aspect is decreased engagement of the patella and trochlea,^4-9,11,26 which results in decreased bony stability in knee extension.^1-3 Therefore, patella alta is one of the potential risk factors for patellar instability with a high percentage of recurrent patellar dislocation.^4-9 In early knee flexion, the patella translates more distally with better engagement of the patella in the trochlea and better stability. Therefore, measurement in extension, with the patellar tendon out to length, seems to offer a more reliable assessment of the patella–femur relationship.

2. Insufficient engagement of the patella in the trochlea is the most important aspect of patella alta.¹¹ Therefore, direct measurement of this engagement seems logical.

3. As radiographs do not show articular cartilage, they should not be used to assess the articular patella–femur relationship.^11,14,26 Patella–trochlea cartilage overlap is the most relevant factor for patella alta and should be measured on MRI.^6,14,26,32

4. PTL is an important factor for patellar height and particularly patella alta. The range of normal PTL values is wide: 35 mm to 61 mm. The described cutoff values for patella alta (>52 mm to >56 mm) fall within this normal range. The cause may be the different measurement methods used.^33,47,59-61 Therefore, for precise diagnostics, a standardized measurement method that includes the selected cut imaging is mandatory.

Conclusion 

Our review revealed many variations in patella alta definitions and descriptions, measurement methods, cutoff values, and treatment options. Presence of patella alta depends on measurement method used. Methods cannot be used interchangeably, and they all have their advantages and limitations. Unfortunately, there is no generally accepted consensus on measurement method, patella alta cutoff value, or treatment with ideal correction. Treatment planning and outcomes assessment require clarification of these many issues.

Take-Home Points

• Patella alta has a reduced articular area of PF contact.
• Presence of patella alta depends on the measurement method.
• Patella alta is defined as ISI >1.2 and CDI >1.2 to >1.3.
• On sagittal MRI, PTI is used most often with cutoff values of <0.125 to 0.28.
• Tibial tubercle distalization is most often used to treat patella alta. The desired postoperative patellar height is a CDI of 1.0.

Patella alta is a patella that rides abnormally high in relation to the femur, the femoral trochlea, or the tibia,¹ with decreased bony stability requiring increased knee flexion angles to engage the trochlea.^2,3 An abnormally high patella may therefore insufficiently engage the proximal trochlea groove both in extension and in the early phase of knee flexion—making it one of the potential risk factors for patellar instability.^4-10 Accordingly, patella alta is present in 30% of patients with recurrent patellar dislocation.¹¹ It also occurs in other disorders, such as knee extensor apparatus disorders, in patients with patellofemoral (PF) pain, chondromalacia, Sinding-Larsen-Johansson disease, Osgood-Schlatter disease, patellar tendinopathy, and osteoarthritis.^1,7,8,12-18 As such, patella alta represents an important predisposing factor for patellar malalignment and PF-related complaints. On the other hand, patella alta may also be a normal variant of a person’s knee anatomy and may be well tolerated when not combined with other instability factors.⁴

Despite the importance of patella alta, there is no consensus on a precise definition, the most reliable measurement method, or the factors thought to be important in clinical decisions regarding treatment. To address this issue, we systematically reviewed the patella alta literature for definitions, the most common measurement methods and their patella alta cutoff values, and cutoff values for surgical correction and proposed surgical techniques.

Methods

In February 2017, using the term patella alta, we performed a systematic literature search on PubMed. Inclusion criteria were original study or review articles, publication in peer-reviewed English-language journals between 2000 and 2017, and narrative description or measurement of human patellar height on plain radiographs or magnetic resonance imaging (MRI). Excluded were abstracts and articles in languages other than English; animal and computational/biomechanical studies; case reports; and knee arthroplasties, knee extensor ruptures, and hereditary and congenital diseases. All evidence levels were included.

We assessed measurement methods, reported cutoff values for patella alta, cutoff values for performing surgical correction, proposed surgical techniques, and postoperative target values. Original study articles and review articles were analyzed separately.

Results

Of 211 articles identified, 92 met the inclusion criteria for original study, and 28 for review. All their abstracts were reviewed, and 91 were excluded: 17 for language other than English, 11 for animal study, 12 for biomechanical/computational study, 20 for case report, 8 for arthroplasty, 13 for hereditary or congenital disease, 1 for extensor apparatus rupture, 3 for editorial letter, and 6 for other reasons. Full text copies of all included articles were obtained and reviewed.

Original Study Articles

Definition. Of the 92 original study articles, 17 (18.5%) defined patella alta by description alone, and 75 (81.5%) used imaging-based measurements. Patella alta was described as a patella that rides abnormally high in relation to the trochlear groove, with a reduced articular area of PF contact^1,15,19-21 or decreased patella–trochlea cartilage overlap.²² With this reduced contact area, there is increased PF stress.²¹

With radiographic measurements, patella alta is defined as a Caton-Deschamps index (CDI) of >1.2 to >1.3, an Insall-Salvati index (ISI) of >1.2, a Blackburne-Peel index (PBI) of >1.0,^{4,15,18,23-25} and a patellotrochlear index (PTI) of <0.125 to 0.28.^6,26

On lateral radiographs, ISI was the most common measurement (33 studies), with patella alta cutoff values ranging from >1.2 to >1.5. The second most common measurement was CDI (24 studies), with cutoff values of >1.2 to >1.3. Other indices, such as the modified ISI (6 studies), the BPI (1 study), and the Koshino index (2 studies), had their cutoff values used more consistently (>1.6 to >2.4, >1.0, and >1.2, respectively) but these indices were rarely reported in the literature (Table 1).^27,28,29 

Thirty-six studies defined patella alta with MRI using either the aforementioned radiographic ratios (23 studies, 3 indices, Table 2) or PF indices (13 studies, 4 methods, Table 3).³⁰ 

On sagittal MRI, PTI was used most often; cutoff values were <0.125 to 0.28.

Thirteen studies defined patella alta with PTL: 5 using lateral conventional radiographs and 8 using sagittal MRI. For each type of imaging, the cutoff value was >52 mm to >56 mm. PTL was measured either independently or together with ISI on sagittal MRI (Table 4).

22

Review Articles

Twenty-eight review articles met the inclusion criteria.^35-40 Patella alta was described mostly with ISI (75%) or CDI (64%). In up to 57% of these articles, a patella alta reference value was missing. Only 1 article mentioned different cutoff values for conventional radiographs and MRI. BPI was mentioned in 50% of studies, but only 2 indicated a cutoff value for patella alta. Eleven percent used PTI on sagittal MRI and took patella–trochlea cartilage overlap into account.

Eight review articles mentioned cutoff values for surgical correction. Only 1 of 4 articles mentioned a cutoff value for correcting patella alta in PF instability, and only 2 articles suggested an ideal postoperative patellar height (Table 6).

No review article relied on PTL to describe patella alta or to advise surgical treatment.

Discussion 

Our review revealed many variations in patella alta definitions and descriptions, measurement methods, cutoff values, and treatment options. Interpretation of patellar height and, particularly, patella alta is very heterogeneous. Accordingly, comparing surgical indications, surgical treatment options, and outcomes across studies can be difficult.

Measurement Methods

Radiographs. Conventional radiographs were used to describe patella alta in two-thirds of the original study articles. The most common measurement methods marked the position of the patella relative to either the femur (direct assessment) or the tibia (indirect assessment).^14,25 All established measurement methods use lateral radiographs, which do not show articular cartilage.^11,14 Therefore, lateral radiograph ratios of different and variable bony landmarks do not measure actual PF articular congruence. The widely variable morphologies of patella (distal patellar nose, different articulating surface), femoral trochlea (facet in height and length), proximal tibia (inherited or acquired deformities on tibial tubercle), and slope are all confounding factors that may affect measurement (Figure 1). In addition, specific variations in PF joint morphology (eg, small patellar articular surface, short trochlea) are not well represented by these ratios.¹¹

All these methods have advantages, limitations, and different values of interobserver and intraobserver variability, reliability, and reproducibility (Table 7).^29,41

Determination of both patellar height and patella alta depends on the measurement method used and is significantly affected by anatomical variants, such as extra-articular patella and femorotibial landmarks. 

The ISI method is most commonly used because it does not depend on degree of knee flexion, is thought to measure the relative length of the patellar tendon the best,⁵ and has established MRI criteria.⁶ However, ISI has limitations: Its distal bony landmark is the tibial tuberosity, which can be difficult to assess¹⁴; the shape of the patella (mainly its inferior point) varies⁴²; and the measurement does not change after distalization of the tibial tubercle.⁵

CDI is the most accurate diagnostic method because it relies on readily identifiable and reproducible anatomical landmarks; does not depend on radiograph quality, knee size, radiologic enlargement, or position of the tibial tubercle or patellar modification; and is unaffected by degree of knee flexion between 10° and 80°.^38,43 CDI is the method that is most useful in describing patellar height after distalization of the tibial tubercle because it assesses the height of the patella relative to the tibial plateau.⁵ CDI is limited with respect to clear identification of the patellar and tibial articular margin.³⁷

BPI has the lowest interobserver variability and discriminates best among patella alta, norma, and infera.⁴¹ Like CDI, BPI assesses patellar height relative to the tibial plateau, and thus is useful in describing patellar height after distalization of the tibial tubercle.⁵ BPI is limited in that it uses a line drawn along the tibial plateau, where variations in inclination and tibial slope produce inaccuracies,¹⁴ and depends highly on projection angles. Clinically, BPI is rarely used.

As the literature shows, the radiologic methods of determining patellar height are variable and unreliable and depend on the ratio used.^26,41 These methods do not reveal precise information about the PF articular congruence, the key finding for necessary treatment.

Radiographic Indices on MRI. Some studies measured radiographic indices on sagittal MRI. Radiologic and MRI measurements are described as not significantly different or slightly different, and 0.09 to 0.13 needs to be added with ISI and BP ratios on radiographs, MRI, and computed tomography (CT).^17,44-47 ISI is commonly used, and its clinical application is easy. Although classically measured on plain radiographs, ISI is reliably measured on MRI as well.^17,30 The traditional 1.2 threshold for defining patella alta was used by Charles and colleagues.⁴⁴ CDI is equally well measured on radiographs and MRI.⁴⁷

According to the literature, 3 different measurement methods have been used to describe degree of patella–trochlea cartilage overlap: PTI, sagittal patellofemoral engagement (SPE), and patellar articular overlap (PAO).^1,11,26

PTI uses the true articular cartilage patella–trochlea relationship for measurement of patellar height on sagittal MRI in extension (Figure 3). If the patellar tendon is fully out to length (no laxity), PTI reliably and precisely determines the exact articular correlation of PF joint and patellar height.⁶

SPE is similar to percentage of articular coverage.^1,11 Patellar overlap of the trochlea is measured on 2 different sagittal MRI images: 1 with the greatest length of patellar cartilage and 1 with the greatest length of femoral trochlear cartilage. This measurement did not correlate with CDI.¹ SPE was not evaluated in control studies, and normal and pathologic values are unavailable.

PAO is measured with patients positioned at rest and in standard knee coils.¹ MRI was not obtained in full extension or with quadriceps activation, and knee flexion angle values are unavailable. Total patellar articular length was measured on the sagittal MRI that showed the greatest patellar length and articular cartilage thickness. The same image was used to measure articular overlap, or the length of patellar cartilage overlying the trochlear cartilage, as measured parallel to the subchondral surface of the patella. PAO correlates well with conventional patellar height measurements in the sagittal plane and shows promise as a simpler alternative to the conventional indices.¹ Normal and pathologic values are unavailable.

So far, PTI is the only method that was controlled in several studies, assessed for its reliability, and compared with other patellar height measurements.^6,14

Patellar Tendon Length. PTL can be measured on lateral radiographs or sagittal MRI. Radiologic and MRI measurements are described as not significantly different⁴⁷ or slightly different, and 0.09 to 0.13 needs to be added with the ISI ratio on radiographs, MRI, and CT.⁴⁶ PTL is reliably evaluated with ISI.^41,50 There is a weak correlation of patient height and PTL: Taller people have normally longer tendons.^51-53

PTL measurements revealed that the posterior surface of the patellar tendon was significantly shorter than the anterior surface. Compared with their corresponding posterior fascicles, anterior fascicles are longer; their attachment is more proximal to the patella and more distal to the tibia. In addition, posterior PTL is significantly shorter with the posterior patellar attachment (adheres to posterior aspect of the inferior patellar pole) than with the anterior attachment (adheres to anterior aspect of the inferior patellar pole).⁵⁶ Moreover, the lateral and medial fascicles are longer than the central fascicles attaching at the most inferior patellar pole. This issue must be considered in image cut selection (Figures 6A, 6B). Furthermore, type of inferior pole of patella (pointed, intermediate, blunt) is important in measurement.⁵⁶ Overall, mean (SD) PTL was 54.9 (1.2) mm on the anterior surface and 35.0 (0.6) mm on the posterior surface.

It is important to precisely describe the measurement method and location (sagittal cut) and to consider the shape of the inferior patellar pole and the site of the patellar tendon attachment.⁵⁶

Treatments. For patella alta, the surgical treatment goals are to increase the PF contact area and improve PF articular congruence, and thereby increase PF stability.^31-33 Four different procedures were used to treat patella alta (Table 5), but only 11 of the 92 original study articles and 8 of the 28 review articles included in our review mentioned a specific patellar height that required surgical correction (Tables 5, 6). Recommendations were based on CDI (>1.2 to >1.4) and less often on ISI (>1.2 to >1.4) or PTL (>56 mm).

Tibial tubercle distalization is effective in normalizing patellar height to correct the patellar index in patella alta (Figures 7A, 7B).^{13,18,38,55,57} Tibial tubercle distalization and patellar tendon tenodesis attached to the original insertion normalize PTL and stabilize the PF joint in patients with patella alta.^5,47 In a comparison of these surgical procedures, cartilage stress was lower with distalization than with distalization and tenodesis.¹³

Soft-tissue methods are recommended in children, as bone procedures injure the proximal tibial physis and may cause it to close prematurely.⁵⁸ The patella can be distally advanced by completely mobilizing the patellar tendon and fixating with sutures through the cartilaginous tibial tubercle. This technique is a satisfactory treatment for skeletally immature patients who present with habitual patellar dislocation associated with patella alta.^58,59

CDI and BPI assess patellar height relative to the tibial plateau, and therefore are the most useful measurement methods for patellar height after distalization of the tibial tubercle.⁵ ISI does not change after distalization of the tibial tubercle and cannot be recommended.^5,18 As PF indices (eg, PTI) can trace preoperative and postoperative values, these measurements are valuable.

Controversies

Our review found no consensus on measurement method or cutoff value. No measurement method showed clear clinical or methodologic superiority. Most published patellar height and patella alta data are based on conventional radiographs using a tibial reference point, even though a femoral or even trochlear reference point seems more reproducible, particularly in PF pathologies. Several cutoff values have been reported for each patella alta measurement method. Regarding pathologic thresholds, which might require surgical correction, very little information has been published, and scientific evidence is lacking. Numerous important aspects remain unanswered after this review, and clarification is mandatory.

Five Key Facts

1. In patella alta assessment, different morphologic, biomechanical, and functional aspects must be considered. The most relevant aspect is decreased engagement of the patella and trochlea,^4-9,11,26 which results in decreased bony stability in knee extension.^1-3 Therefore, patella alta is one of the potential risk factors for patellar instability with a high percentage of recurrent patellar dislocation.^4-9 In early knee flexion, the patella translates more distally with better engagement of the patella in the trochlea and better stability. Therefore, measurement in extension, with the patellar tendon out to length, seems to offer a more reliable assessment of the patella–femur relationship.

2. Insufficient engagement of the patella in the trochlea is the most important aspect of patella alta.¹¹ Therefore, direct measurement of this engagement seems logical.

3. As radiographs do not show articular cartilage, they should not be used to assess the articular patella–femur relationship.^11,14,26 Patella–trochlea cartilage overlap is the most relevant factor for patella alta and should be measured on MRI.^6,14,26,32

4. PTL is an important factor for patellar height and particularly patella alta. The range of normal PTL values is wide: 35 mm to 61 mm. The described cutoff values for patella alta (>52 mm to >56 mm) fall within this normal range. The cause may be the different measurement methods used.^33,47,59-61 Therefore, for precise diagnostics, a standardized measurement method that includes the selected cut imaging is mandatory.

Conclusion 

Our review revealed many variations in patella alta definitions and descriptions, measurement methods, cutoff values, and treatment options. Presence of patella alta depends on measurement method used. Methods cannot be used interchangeably, and they all have their advantages and limitations. Unfortunately, there is no generally accepted consensus on measurement method, patella alta cutoff value, or treatment with ideal correction. Treatment planning and outcomes assessment require clarification of these many issues.

Take-Home Points

• There is no difference in PROMs following knotless or knotted labral repair.
• Operative time is shorter for knotless compared to knotted glenoid labral tears.
• Knotless constructs may be more predictable than knotted constructs biomechanically.

Orthopedic surgeons often encounter labral pathology, and labral tears historically have required open techniques.^1-3 Arthroscopy allows for advanced visualization and treatment of shoulder lesions,^4,5 including anterior, posterior, and superior labrum anterior to posterior (SLAP) lesions.⁶

The goal of arthroscopic labral repair is to restore joint stability while maintaining range of motion. Arthroscopically repairing the labrum with suture anchors has become the standard technique, and several studies have reported satisfactory biomechanical and clinical results.^1,7-12 Surgeons traditionally have been required to tie knots for these anchors, but knot security varies significantly among experienced arthroscopic surgeons.¹³ In addition, knots can migrate,¹⁴ and bulky knots can cause chondral abrasion.^15,16 Several manufacturers have introduced knotless anchors for soft-tissue fixation.^15,17 The knotless technique provides a low-profile repair with potentially less operating time.⁸ These factors may warrant switching from knotted to knotless techniques if outcomes are clinically acceptable. However, few studies have compared knotted and knotless techniques for glenohumeral labral repair.^8,15,18-21

We conducted a study to compare the clinical results and operative times of knotless and knotted fixation of anterior and posterior glenohumeral labral repairs and SLAP repairs. We hypothesized there would be no difference in patient-reported outcome measures (PROMs) between knotted and knotless techniques.

Methods

We retrospectively evaluated data that had been prospectively collected between 2012 and 2016 in a Surgical Outcomes System (SOS; Arthrex) database. Participation in this registry is elective, and enrollment can occur on a case-by-case basis. The database stores data on basic demographics, PROMs, and operative time. Data for our specific analysis were available for surgeries performed by 115 different surgeons. Inclusion criteria included primary isolated arthroscopic anterior, isolated posterior, and isolated SLAP repair with completely knotted or completely knotless labral repair and minimum 1-year follow-up. Exclusion criteria included hybrid knotted–knotless repair, rotator cuff repair, revision surgery, open surgery, and lack of complete follow-up data.

SOS is a proprietary registry that allows for the collection of basic patient demographics, diagnostic and operative data, and PROMs. PROMs in the SOS shoulder arthroscopy module include Veterans RAND 12-Item Health Survey (VR-12) mental health and physical health component summary scores, visual analog scale (VAS) pain scores, and American Shoulder and Elbow Surgeons (ASES) scores. For this study, PROMs were reviewed before surgery and 6 and 12 months after surgery. In addition, operative times of all procedures were collected.

For the analysis, completely knotted and completely knotless techniques were compared for anterior repair, posterior repair, and SLAP repair. A t test was used to compare the techniques on PROMs, and χ2 test was used to evaluate proportion differences. Statistical significance was set at P < .05. 

Results

Anterior Labral Repairs

Of the 102 knotted anterior labral repairs that met the study criteria, 26 (25%) had minimum 1-year follow-up. Of the 122 knotless labral repairs, 33 (27%) had minimum 1-year follow-up. Seventy-five percent of knotted repairs and 80% of knotless repairs were performed in men. Mean (SD) age was 25.3 (11.7) years for the knotted group and 26.9 (10.6) years for the knotless group (P = .109). Anterior labral repairs did not differ in PROMs at any point (Table 1).

A mean of 2.8 anchors was used for knotted repairs, and a mean of 3.1 anchors was used for knotless repairs. Mean operative time was 75.8 minutes for knotted repairs and 67.5 minutes for knotless repairs. Mean (SD) time per anchor was 30.9 (13.9) minutes for knotted repairs and 25.6 (19.5) minutes for knotless repairs (P = .021). 

Posterior Labral Repairs

Of the 165 knotted posterior labral repairs that met the study criteria, 39 (29%) had minimum 1-year follow-up. Of the 229 knotless labral repairs, 56 (24%) had minimum 1-year follow-up. Eighty-five percent of knotted repairs and 74% of knotless repairs were performed in men. Mean (SD) age was 29.1 (12.0) years for the knotted group and 27.5 (11.9) years for the knotless group (P = .148). Posterior labral repairs did not differ in PROMs before surgery or 1 year after surgery; 6 months after surgery, these repairs differed only in ASES scores (Table 2). 

A mean of 3.6 anchors was used for knotted repairs, and a mean of 3.0 anchors was used for knotless repairs. Mean operative time was 67.0 minutes for knotted repairs and 43.1 minutes for knotless repairs. Mean (SD) time per anchor was 21.1 (10.7) minutes for knotted repairs and 17.5 (14.7) minutes for knotless repairs (P = .031).

SLAP Repairs

Of the 54 knotted SLAP repairs that met the study criteria, 24 (44%) had minimum 1-year follow-up. Of the 138 knotless SLAP repairs, 48 (35%) had minimum 1-year follow-up. Seventy-two percent of knotted repairs and 72% of knotless repairs were performed in men. Mean (SD) age was 32.1 (11.6) years for the knotted group and 35.0 (12.8) years for the knotless group (P = .246). SLAP repairs did not differ in PROMs at any point (Table 3).

A mean of 1.9 anchors was used for knotted repairs, and a mean of 2.1 anchors was used for knotless repairs. Mean operative time was 59.0 minutes for knotted repairs and 40.9 minutes for knotless repairs. Mean (SD) time per anchor was 36.6 (22.4) minutes for knotted repairs and 26.3 (14.0) minutes for knotless repairs (P = .080).

Discussion

Our hypothesis that there would be no difference in PROMs between knotted and knotless labral repairs was confirmed. Our findings are important because this study compared the gold standard of knotted suture anchor with the alternative knotless suture anchor in glenohumeral labral repair. These findings have several important implications for labral repair.

Knot tying traditionally has been used to achieve fixation with an anchor. Although simple in concept, knot tying can be challenging and its quality variable. Thal¹⁵ wrote that good-quality arthroscopic suture anchor repair is difficult to achieve because satisfactory knot tying requires significant practice with certain devices designed specifically for knot tying. Multiple surgeons have noted a significant learning curve associated with knot tying, and there is no agreement on which knot is superior.^22-26 Leedle and Miller¹⁷ even suggested that, because knot tying is difficult, tying knots arthroscopically can lead to knot failure. In their study, they concluded that the knot is consistently the weakest link in suture repair of an anterior labrum construct. In a controlled laboratory study, Hanypsiak and colleagues¹³ found considerable knot-strength variability among expert arthroscopists. Only 65 (18%) of 365 knots tied fell within 20% of the mean for ultimate load failure, and only 128 (36%) of 365 fell within 20% of the mean for clinical failure (3 mm of displacement). These data suggested expert arthroscopists were unable to tie 5 consecutive knots of the same type consistently. Even among experts, it seems, knot strength varies significantly, and knot-strength issues may affect the rates of labral repair failure.

Multiple authors have also reported that bulky knots can cause chondral abrasion or that knots can migrate.^25,27 Rhee and Ha²⁷ reported that, when another knot (eg, a half-hitch knot) is tied to prevent knot failure, the resulting overall knot can be too bulky for a limited space, and chondral abrasion can result. In addition, regardless of size, a knot can migrate and, in its new position, start rubbing against the head of the humerus. Kim and colleagues¹⁴ found that, even when a knot is placed away from the humeral head, migration and repeated contact with the head are possible. Park and colleagues²⁸ found that a significant number of knotted SLAP repairs required arthroscopic knot removal for relief of knot-induced pain and clicking.

Knotless constructs have several theoretical advantages over knotted constructs. Compared with a knotted technique, a knotless technique appears to provide more predictable strength, as variability in knot tying is eliminated (unpublished data). A knotless repair also has a lower profile,8 which should lead to less contact with the humeral head.¹⁹ Last, a knotless repair is more efficient—it takes less time to perform. In our study, operative time was reduced by a mean of 5.3 minutes per anchor for anterior labral repair. Assuming a mean of 3 anchors, this reduction equates to 16 minutes per case. Therefore, a surgeon who performs 25 labral repairs a year can save 6.7 hours a year. Reduced operative time benefits the patient (ie, lower risk of infection and other complications²⁹), the surgeon, and the healthcare system (ie, cost savings). Macario³⁰ found that operating room costs averaged $62 per minute (range, $22-$133 per minute). Therefore, saving 16 minutes per case could lead to saving $992 per case. In summary, a knotless technique appears to be clinically and financially advantageous as long as its results are the same as or better than those of a knotted technique.

A few other studies have compared knotted and knotless techniques. In a cadaveric study, Slabaugh and colleagues²⁰ found no difference in labral height between traditional and knotless suture anchors. Leedle and Miller¹⁷ found that knotless constructs are biomechanically stronger than knotted constructs in anterior labral repair. In a level 3 clinical study, Yang and colleagues²¹ compared a conventional vertical knot with a knotless horizontal mattress suture in 41 patients who underwent SLAP repair. Functional outcome was no different between the 2 groups, but postoperative range of motion was improved in the knotless group. Ng and Kumar³¹ compared 45 patients who had knotted Bankart repair with 42 patients who had knotless Bankart repair and found no difference in functional outcome or rate of recurrent dislocation. Similarly, Kocaoglu and colleagues²² found no difference in recurrence rate between 18 patients who underwent a knotted technique for arthroscopic Bankart repair and 20 patients who underwent a knotless technique. Our findings corroborate the findings of these studies and further support the idea that there is no difference between knotted and knotless constructs with respect to PROMs.

Study Limitations

The major strength of this study was its large cohort and large population of surgeons. However, there were several study limitations. First, we could not detail specific repair techniques, such as simple or horizontal mattress orientation, and rehabilitation protocols and other variables are likely as well. Second, the repair technique was not randomized, and therefore there may have been a selection bias based on tissue quality. Although we cannot prove no bias, we think it was unlikely given that the groups were similar in age. Third, our data did not include information on range of motion or recurrent instability. Our goal was simply to evaluate PROMs among multiple surgeons using the 2 techniques. Fourth, there was substantial follow-up loss, which introduced potential selection bias. Last, there may have been conditions under which a hybrid technique with inferior knot tying, combined with a hybrid knotless construct, could have proved advantageous.

Conclusion

Our data showed that the advantages of knotless repair are not compromised in clinical situations. Although the data showed no significant difference in clinical outcomes, knotless repairs may provide surgeons with shorter surgeries, simpler constructs, less potential for chondral damage, and more consistent suture tensioning. Additional studies may further confirm these results.

Take-Home Points

• There is no difference in PROMs following knotless or knotted labral repair.
• Operative time is shorter for knotless compared to knotted glenoid labral tears.
• Knotless constructs may be more predictable than knotted constructs biomechanically.

Orthopedic surgeons often encounter labral pathology, and labral tears historically have required open techniques.^1-3 Arthroscopy allows for advanced visualization and treatment of shoulder lesions,^4,5 including anterior, posterior, and superior labrum anterior to posterior (SLAP) lesions.⁶

The goal of arthroscopic labral repair is to restore joint stability while maintaining range of motion. Arthroscopically repairing the labrum with suture anchors has become the standard technique, and several studies have reported satisfactory biomechanical and clinical results.^1,7-12 Surgeons traditionally have been required to tie knots for these anchors, but knot security varies significantly among experienced arthroscopic surgeons.¹³ In addition, knots can migrate,¹⁴ and bulky knots can cause chondral abrasion.^15,16 Several manufacturers have introduced knotless anchors for soft-tissue fixation.^15,17 The knotless technique provides a low-profile repair with potentially less operating time.⁸ These factors may warrant switching from knotted to knotless techniques if outcomes are clinically acceptable. However, few studies have compared knotted and knotless techniques for glenohumeral labral repair.^8,15,18-21

We conducted a study to compare the clinical results and operative times of knotless and knotted fixation of anterior and posterior glenohumeral labral repairs and SLAP repairs. We hypothesized there would be no difference in patient-reported outcome measures (PROMs) between knotted and knotless techniques.

Methods

We retrospectively evaluated data that had been prospectively collected between 2012 and 2016 in a Surgical Outcomes System (SOS; Arthrex) database. Participation in this registry is elective, and enrollment can occur on a case-by-case basis. The database stores data on basic demographics, PROMs, and operative time. Data for our specific analysis were available for surgeries performed by 115 different surgeons. Inclusion criteria included primary isolated arthroscopic anterior, isolated posterior, and isolated SLAP repair with completely knotted or completely knotless labral repair and minimum 1-year follow-up. Exclusion criteria included hybrid knotted–knotless repair, rotator cuff repair, revision surgery, open surgery, and lack of complete follow-up data.

SOS is a proprietary registry that allows for the collection of basic patient demographics, diagnostic and operative data, and PROMs. PROMs in the SOS shoulder arthroscopy module include Veterans RAND 12-Item Health Survey (VR-12) mental health and physical health component summary scores, visual analog scale (VAS) pain scores, and American Shoulder and Elbow Surgeons (ASES) scores. For this study, PROMs were reviewed before surgery and 6 and 12 months after surgery. In addition, operative times of all procedures were collected.

For the analysis, completely knotted and completely knotless techniques were compared for anterior repair, posterior repair, and SLAP repair. A t test was used to compare the techniques on PROMs, and χ2 test was used to evaluate proportion differences. Statistical significance was set at P < .05. 

Results

Anterior Labral Repairs

Of the 102 knotted anterior labral repairs that met the study criteria, 26 (25%) had minimum 1-year follow-up. Of the 122 knotless labral repairs, 33 (27%) had minimum 1-year follow-up. Seventy-five percent of knotted repairs and 80% of knotless repairs were performed in men. Mean (SD) age was 25.3 (11.7) years for the knotted group and 26.9 (10.6) years for the knotless group (P = .109). Anterior labral repairs did not differ in PROMs at any point (Table 1).

A mean of 2.8 anchors was used for knotted repairs, and a mean of 3.1 anchors was used for knotless repairs. Mean operative time was 75.8 minutes for knotted repairs and 67.5 minutes for knotless repairs. Mean (SD) time per anchor was 30.9 (13.9) minutes for knotted repairs and 25.6 (19.5) minutes for knotless repairs (P = .021). 

Posterior Labral Repairs

Of the 165 knotted posterior labral repairs that met the study criteria, 39 (29%) had minimum 1-year follow-up. Of the 229 knotless labral repairs, 56 (24%) had minimum 1-year follow-up. Eighty-five percent of knotted repairs and 74% of knotless repairs were performed in men. Mean (SD) age was 29.1 (12.0) years for the knotted group and 27.5 (11.9) years for the knotless group (P = .148). Posterior labral repairs did not differ in PROMs before surgery or 1 year after surgery; 6 months after surgery, these repairs differed only in ASES scores (Table 2). 

A mean of 3.6 anchors was used for knotted repairs, and a mean of 3.0 anchors was used for knotless repairs. Mean operative time was 67.0 minutes for knotted repairs and 43.1 minutes for knotless repairs. Mean (SD) time per anchor was 21.1 (10.7) minutes for knotted repairs and 17.5 (14.7) minutes for knotless repairs (P = .031).

SLAP Repairs

Of the 54 knotted SLAP repairs that met the study criteria, 24 (44%) had minimum 1-year follow-up. Of the 138 knotless SLAP repairs, 48 (35%) had minimum 1-year follow-up. Seventy-two percent of knotted repairs and 72% of knotless repairs were performed in men. Mean (SD) age was 32.1 (11.6) years for the knotted group and 35.0 (12.8) years for the knotless group (P = .246). SLAP repairs did not differ in PROMs at any point (Table 3).

A mean of 1.9 anchors was used for knotted repairs, and a mean of 2.1 anchors was used for knotless repairs. Mean operative time was 59.0 minutes for knotted repairs and 40.9 minutes for knotless repairs. Mean (SD) time per anchor was 36.6 (22.4) minutes for knotted repairs and 26.3 (14.0) minutes for knotless repairs (P = .080).

Discussion

Our hypothesis that there would be no difference in PROMs between knotted and knotless labral repairs was confirmed. Our findings are important because this study compared the gold standard of knotted suture anchor with the alternative knotless suture anchor in glenohumeral labral repair. These findings have several important implications for labral repair.

Knot tying traditionally has been used to achieve fixation with an anchor. Although simple in concept, knot tying can be challenging and its quality variable. Thal¹⁵ wrote that good-quality arthroscopic suture anchor repair is difficult to achieve because satisfactory knot tying requires significant practice with certain devices designed specifically for knot tying. Multiple surgeons have noted a significant learning curve associated with knot tying, and there is no agreement on which knot is superior.^22-26 Leedle and Miller¹⁷ even suggested that, because knot tying is difficult, tying knots arthroscopically can lead to knot failure. In their study, they concluded that the knot is consistently the weakest link in suture repair of an anterior labrum construct. In a controlled laboratory study, Hanypsiak and colleagues¹³ found considerable knot-strength variability among expert arthroscopists. Only 65 (18%) of 365 knots tied fell within 20% of the mean for ultimate load failure, and only 128 (36%) of 365 fell within 20% of the mean for clinical failure (3 mm of displacement). These data suggested expert arthroscopists were unable to tie 5 consecutive knots of the same type consistently. Even among experts, it seems, knot strength varies significantly, and knot-strength issues may affect the rates of labral repair failure.

Multiple authors have also reported that bulky knots can cause chondral abrasion or that knots can migrate.^25,27 Rhee and Ha²⁷ reported that, when another knot (eg, a half-hitch knot) is tied to prevent knot failure, the resulting overall knot can be too bulky for a limited space, and chondral abrasion can result. In addition, regardless of size, a knot can migrate and, in its new position, start rubbing against the head of the humerus. Kim and colleagues¹⁴ found that, even when a knot is placed away from the humeral head, migration and repeated contact with the head are possible. Park and colleagues²⁸ found that a significant number of knotted SLAP repairs required arthroscopic knot removal for relief of knot-induced pain and clicking.

Knotless constructs have several theoretical advantages over knotted constructs. Compared with a knotted technique, a knotless technique appears to provide more predictable strength, as variability in knot tying is eliminated (unpublished data). A knotless repair also has a lower profile,8 which should lead to less contact with the humeral head.¹⁹ Last, a knotless repair is more efficient—it takes less time to perform. In our study, operative time was reduced by a mean of 5.3 minutes per anchor for anterior labral repair. Assuming a mean of 3 anchors, this reduction equates to 16 minutes per case. Therefore, a surgeon who performs 25 labral repairs a year can save 6.7 hours a year. Reduced operative time benefits the patient (ie, lower risk of infection and other complications²⁹), the surgeon, and the healthcare system (ie, cost savings). Macario³⁰ found that operating room costs averaged $62 per minute (range, $22-$133 per minute). Therefore, saving 16 minutes per case could lead to saving $992 per case. In summary, a knotless technique appears to be clinically and financially advantageous as long as its results are the same as or better than those of a knotted technique.

A few other studies have compared knotted and knotless techniques. In a cadaveric study, Slabaugh and colleagues²⁰ found no difference in labral height between traditional and knotless suture anchors. Leedle and Miller¹⁷ found that knotless constructs are biomechanically stronger than knotted constructs in anterior labral repair. In a level 3 clinical study, Yang and colleagues²¹ compared a conventional vertical knot with a knotless horizontal mattress suture in 41 patients who underwent SLAP repair. Functional outcome was no different between the 2 groups, but postoperative range of motion was improved in the knotless group. Ng and Kumar³¹ compared 45 patients who had knotted Bankart repair with 42 patients who had knotless Bankart repair and found no difference in functional outcome or rate of recurrent dislocation. Similarly, Kocaoglu and colleagues²² found no difference in recurrence rate between 18 patients who underwent a knotted technique for arthroscopic Bankart repair and 20 patients who underwent a knotless technique. Our findings corroborate the findings of these studies and further support the idea that there is no difference between knotted and knotless constructs with respect to PROMs.

Study Limitations

The major strength of this study was its large cohort and large population of surgeons. However, there were several study limitations. First, we could not detail specific repair techniques, such as simple or horizontal mattress orientation, and rehabilitation protocols and other variables are likely as well. Second, the repair technique was not randomized, and therefore there may have been a selection bias based on tissue quality. Although we cannot prove no bias, we think it was unlikely given that the groups were similar in age. Third, our data did not include information on range of motion or recurrent instability. Our goal was simply to evaluate PROMs among multiple surgeons using the 2 techniques. Fourth, there was substantial follow-up loss, which introduced potential selection bias. Last, there may have been conditions under which a hybrid technique with inferior knot tying, combined with a hybrid knotless construct, could have proved advantageous.

Conclusion

Our data showed that the advantages of knotless repair are not compromised in clinical situations. Although the data showed no significant difference in clinical outcomes, knotless repairs may provide surgeons with shorter surgeries, simpler constructs, less potential for chondral damage, and more consistent suture tensioning. Additional studies may further confirm these results.

Take-Home Points

• There is no difference in PROMs following knotless or knotted labral repair.
• Operative time is shorter for knotless compared to knotted glenoid labral tears.
• Knotless constructs may be more predictable than knotted constructs biomechanically.

Orthopedic surgeons often encounter labral pathology, and labral tears historically have required open techniques.^1-3 Arthroscopy allows for advanced visualization and treatment of shoulder lesions,^4,5 including anterior, posterior, and superior labrum anterior to posterior (SLAP) lesions.⁶

The goal of arthroscopic labral repair is to restore joint stability while maintaining range of motion. Arthroscopically repairing the labrum with suture anchors has become the standard technique, and several studies have reported satisfactory biomechanical and clinical results.^1,7-12 Surgeons traditionally have been required to tie knots for these anchors, but knot security varies significantly among experienced arthroscopic surgeons.¹³ In addition, knots can migrate,¹⁴ and bulky knots can cause chondral abrasion.^15,16 Several manufacturers have introduced knotless anchors for soft-tissue fixation.^15,17 The knotless technique provides a low-profile repair with potentially less operating time.⁸ These factors may warrant switching from knotted to knotless techniques if outcomes are clinically acceptable. However, few studies have compared knotted and knotless techniques for glenohumeral labral repair.^8,15,18-21

We conducted a study to compare the clinical results and operative times of knotless and knotted fixation of anterior and posterior glenohumeral labral repairs and SLAP repairs. We hypothesized there would be no difference in patient-reported outcome measures (PROMs) between knotted and knotless techniques.

Methods

We retrospectively evaluated data that had been prospectively collected between 2012 and 2016 in a Surgical Outcomes System (SOS; Arthrex) database. Participation in this registry is elective, and enrollment can occur on a case-by-case basis. The database stores data on basic demographics, PROMs, and operative time. Data for our specific analysis were available for surgeries performed by 115 different surgeons. Inclusion criteria included primary isolated arthroscopic anterior, isolated posterior, and isolated SLAP repair with completely knotted or completely knotless labral repair and minimum 1-year follow-up. Exclusion criteria included hybrid knotted–knotless repair, rotator cuff repair, revision surgery, open surgery, and lack of complete follow-up data.

SOS is a proprietary registry that allows for the collection of basic patient demographics, diagnostic and operative data, and PROMs. PROMs in the SOS shoulder arthroscopy module include Veterans RAND 12-Item Health Survey (VR-12) mental health and physical health component summary scores, visual analog scale (VAS) pain scores, and American Shoulder and Elbow Surgeons (ASES) scores. For this study, PROMs were reviewed before surgery and 6 and 12 months after surgery. In addition, operative times of all procedures were collected.

For the analysis, completely knotted and completely knotless techniques were compared for anterior repair, posterior repair, and SLAP repair. A t test was used to compare the techniques on PROMs, and χ2 test was used to evaluate proportion differences. Statistical significance was set at P < .05. 

Results

Anterior Labral Repairs

Of the 102 knotted anterior labral repairs that met the study criteria, 26 (25%) had minimum 1-year follow-up. Of the 122 knotless labral repairs, 33 (27%) had minimum 1-year follow-up. Seventy-five percent of knotted repairs and 80% of knotless repairs were performed in men. Mean (SD) age was 25.3 (11.7) years for the knotted group and 26.9 (10.6) years for the knotless group (P = .109). Anterior labral repairs did not differ in PROMs at any point (Table 1).

A mean of 2.8 anchors was used for knotted repairs, and a mean of 3.1 anchors was used for knotless repairs. Mean operative time was 75.8 minutes for knotted repairs and 67.5 minutes for knotless repairs. Mean (SD) time per anchor was 30.9 (13.9) minutes for knotted repairs and 25.6 (19.5) minutes for knotless repairs (P = .021). 

Posterior Labral Repairs

Of the 165 knotted posterior labral repairs that met the study criteria, 39 (29%) had minimum 1-year follow-up. Of the 229 knotless labral repairs, 56 (24%) had minimum 1-year follow-up. Eighty-five percent of knotted repairs and 74% of knotless repairs were performed in men. Mean (SD) age was 29.1 (12.0) years for the knotted group and 27.5 (11.9) years for the knotless group (P = .148). Posterior labral repairs did not differ in PROMs before surgery or 1 year after surgery; 6 months after surgery, these repairs differed only in ASES scores (Table 2). 

A mean of 3.6 anchors was used for knotted repairs, and a mean of 3.0 anchors was used for knotless repairs. Mean operative time was 67.0 minutes for knotted repairs and 43.1 minutes for knotless repairs. Mean (SD) time per anchor was 21.1 (10.7) minutes for knotted repairs and 17.5 (14.7) minutes for knotless repairs (P = .031).

SLAP Repairs

Of the 54 knotted SLAP repairs that met the study criteria, 24 (44%) had minimum 1-year follow-up. Of the 138 knotless SLAP repairs, 48 (35%) had minimum 1-year follow-up. Seventy-two percent of knotted repairs and 72% of knotless repairs were performed in men. Mean (SD) age was 32.1 (11.6) years for the knotted group and 35.0 (12.8) years for the knotless group (P = .246). SLAP repairs did not differ in PROMs at any point (Table 3).

A mean of 1.9 anchors was used for knotted repairs, and a mean of 2.1 anchors was used for knotless repairs. Mean operative time was 59.0 minutes for knotted repairs and 40.9 minutes for knotless repairs. Mean (SD) time per anchor was 36.6 (22.4) minutes for knotted repairs and 26.3 (14.0) minutes for knotless repairs (P = .080).

Discussion

Our hypothesis that there would be no difference in PROMs between knotted and knotless labral repairs was confirmed. Our findings are important because this study compared the gold standard of knotted suture anchor with the alternative knotless suture anchor in glenohumeral labral repair. These findings have several important implications for labral repair.

Knot tying traditionally has been used to achieve fixation with an anchor. Although simple in concept, knot tying can be challenging and its quality variable. Thal¹⁵ wrote that good-quality arthroscopic suture anchor repair is difficult to achieve because satisfactory knot tying requires significant practice with certain devices designed specifically for knot tying. Multiple surgeons have noted a significant learning curve associated with knot tying, and there is no agreement on which knot is superior.^22-26 Leedle and Miller¹⁷ even suggested that, because knot tying is difficult, tying knots arthroscopically can lead to knot failure. In their study, they concluded that the knot is consistently the weakest link in suture repair of an anterior labrum construct. In a controlled laboratory study, Hanypsiak and colleagues¹³ found considerable knot-strength variability among expert arthroscopists. Only 65 (18%) of 365 knots tied fell within 20% of the mean for ultimate load failure, and only 128 (36%) of 365 fell within 20% of the mean for clinical failure (3 mm of displacement). These data suggested expert arthroscopists were unable to tie 5 consecutive knots of the same type consistently. Even among experts, it seems, knot strength varies significantly, and knot-strength issues may affect the rates of labral repair failure.

Multiple authors have also reported that bulky knots can cause chondral abrasion or that knots can migrate.^25,27 Rhee and Ha²⁷ reported that, when another knot (eg, a half-hitch knot) is tied to prevent knot failure, the resulting overall knot can be too bulky for a limited space, and chondral abrasion can result. In addition, regardless of size, a knot can migrate and, in its new position, start rubbing against the head of the humerus. Kim and colleagues¹⁴ found that, even when a knot is placed away from the humeral head, migration and repeated contact with the head are possible. Park and colleagues²⁸ found that a significant number of knotted SLAP repairs required arthroscopic knot removal for relief of knot-induced pain and clicking.

Knotless constructs have several theoretical advantages over knotted constructs. Compared with a knotted technique, a knotless technique appears to provide more predictable strength, as variability in knot tying is eliminated (unpublished data). A knotless repair also has a lower profile,8 which should lead to less contact with the humeral head.¹⁹ Last, a knotless repair is more efficient—it takes less time to perform. In our study, operative time was reduced by a mean of 5.3 minutes per anchor for anterior labral repair. Assuming a mean of 3 anchors, this reduction equates to 16 minutes per case. Therefore, a surgeon who performs 25 labral repairs a year can save 6.7 hours a year. Reduced operative time benefits the patient (ie, lower risk of infection and other complications²⁹), the surgeon, and the healthcare system (ie, cost savings). Macario³⁰ found that operating room costs averaged $62 per minute (range, $22-$133 per minute). Therefore, saving 16 minutes per case could lead to saving $992 per case. In summary, a knotless technique appears to be clinically and financially advantageous as long as its results are the same as or better than those of a knotted technique.

A few other studies have compared knotted and knotless techniques. In a cadaveric study, Slabaugh and colleagues²⁰ found no difference in labral height between traditional and knotless suture anchors. Leedle and Miller¹⁷ found that knotless constructs are biomechanically stronger than knotted constructs in anterior labral repair. In a level 3 clinical study, Yang and colleagues²¹ compared a conventional vertical knot with a knotless horizontal mattress suture in 41 patients who underwent SLAP repair. Functional outcome was no different between the 2 groups, but postoperative range of motion was improved in the knotless group. Ng and Kumar³¹ compared 45 patients who had knotted Bankart repair with 42 patients who had knotless Bankart repair and found no difference in functional outcome or rate of recurrent dislocation. Similarly, Kocaoglu and colleagues²² found no difference in recurrence rate between 18 patients who underwent a knotted technique for arthroscopic Bankart repair and 20 patients who underwent a knotless technique. Our findings corroborate the findings of these studies and further support the idea that there is no difference between knotted and knotless constructs with respect to PROMs.

Study Limitations

The major strength of this study was its large cohort and large population of surgeons. However, there were several study limitations. First, we could not detail specific repair techniques, such as simple or horizontal mattress orientation, and rehabilitation protocols and other variables are likely as well. Second, the repair technique was not randomized, and therefore there may have been a selection bias based on tissue quality. Although we cannot prove no bias, we think it was unlikely given that the groups were similar in age. Third, our data did not include information on range of motion or recurrent instability. Our goal was simply to evaluate PROMs among multiple surgeons using the 2 techniques. Fourth, there was substantial follow-up loss, which introduced potential selection bias. Last, there may have been conditions under which a hybrid technique with inferior knot tying, combined with a hybrid knotless construct, could have proved advantageous.

Conclusion

Our data showed that the advantages of knotless repair are not compromised in clinical situations. Although the data showed no significant difference in clinical outcomes, knotless repairs may provide surgeons with shorter surgeries, simpler constructs, less potential for chondral damage, and more consistent suture tensioning. Additional studies may further confirm these results.

Take-Home Points

• PRO data collection can provide feedback for improvements in patient care and physician performance.
• Many options exist for orthopedic physicians to establish clinical data registries.
• Registry systems can help improve patient follow-up with system monitoring and patient reminders.
• Clinical registries can offer many advantages to observational research.
• With registry use becoming more prevalent, work needs to be done to establish standards for validity and reliability.

In a 2012 review of database tools, Lubowitz and Smith¹ examined Internet-based applications that arthroscopic surgeons could use to record and monitor patient-reported outcome (PRO) data and potential adverse effects. In this article, we update orthopedic surgeons on the registries and monitoring software mentioned in that earlier publication and in other publications that have since become available.

Most orthopedic surgery candidates are seeking pain relief and improved function. Many patients expect their pain to be completely relieved by surgical intervention and their function to return to what it was before they became stricken.^2,3 Therefore, PRO measures (PROMs) are now standard in post-orthopedic surgery outcome reporting.⁴ PROMs, which include any measurement that assesses a patient’s health, illness, or benefits from the perspective of the patient, are often administered as a questionnaire or survey.⁵ The collection of PROMs continues to increase and evolve, creating a need for data storage and analysis. Registries, large collections of patient information and outcomes, allow for evaluation of patient outcomes, monitoring of adverse effects, identification of procedure incidence, understanding of predictors of prognosis, generation of feedback for quality of care, monitoring of the safety of implantable devices, and the conducting of hypothesis-driven scientific research.^6-9

Orthopedic surgery has registries at regional, national, and international levels. Although the United States has fallen well behind other countries in establishing a national registry,⁹ it has made some recent progress. The United States now has several national registries, including the American Joint Replacement Registry (AJRR), Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), the Kaiser Permanente National Total Joint Replacement Registry (TJRR), the Veterans Affairs (VA) and American College of Surgeons (ACS) National Surgical Quality Improvement Programs (NSQIPs), and the National Trauma Data Bank (NTDB).⁹ AJRR currently has 960 hospitals participating and is tracking 1,084,664 hip and knee replacements.¹⁰

These orthopedic registries, however, are limited in 2 ways. First, the majority are joint replacement registries. Second, though registries are established to determine patterns of care and predict patient outcomes, many are not set up to report care data back to healthcare providers.⁷ For procedures other than joint arthroplasty and for providers interested in tracking their patients’ PROs, systems are available for establishing clinical quality registries in orthopedics.

Registry Systems

CareSense

CareSense (Medtrak) is an Internet-based care management and data collection system designed for patient engagement, which results in fewer missed appointments, increased patient adherence, enhanced patient education, and improved patient satisfaction.¹¹ CareSense features email/text reminders for data entry, custom and standard reports, import and export of electronic medical record (EMR) information, and tools for running research studies.¹² CareSense emphasizes care navigation by helping hospitals educate and guide patients through their care by sending exercise videos to patients for home rehabilitation, transferring messages from post-acute care facilities to surgeons and caregivers, and alerting the care team to any potential readmission symptoms.^11,13 CareSense is also a Centers for Medicare & Medicaid Services (CMS) approved qualified clinical data registry (QCDR). QCDRs collect data for Merit-Based Incentive Payment System (MIPS) clinicians and submit the data to CMS.¹²

KareOutcomes

KareOutcomes, a healthcare technology and support firm founded in 2009, advocates transparency and trust among providers and patients, and aims to optimize PROs.¹⁴ The KareOutcomes team incorporates patient follow-up personnel, administrators, engineers, physicians, software developers, and technicians. The KareOutcomes software, which is backed by a 6-month guarantee, includes system design and implementation, data collection and entry, methods of submitting data to statewide or nationwide registries and sending standardized and customized surveys, and accessible and meaningful data presentation. KareOutcomes allows patient follow-up through automated reminders by telephone, SMS text message, and email. Patients can respond to surveys or questionnaires whichever way is most convenient—by telephone, Internet, SMS text message, or on paper, either in the office or by mail.

Oberd

Oberd (Universal Research Solutions) offers a comprehensive package of solutions for collecting optimal PRO data. The package has several modules: outcomes, education, registry, operative notes, data import and export, and data reporting.¹⁵ Oberd Outcomes allows convenient and engaging data collection. For example, users can send both standardized and customized forms. Oberd Education allows patients to receive information in an interactive, narrated format that is specific to their physician’s techniques and practices. Oberd Registry allows users to input multiple datasets into a registry, compare data, and generate reports with visuals. Like CareSense, Oberd is a CMS-approved QCDR. Oberd’s MIPS Dashboard helps providers collect and report patients’ reported outcomes, and use that information to modify and improve their practice.

Ortech

Ortech is a web-based data registry system that allows physicians and administrators to mine the data they own, track key metrics in their data, and improve reporting.¹⁶ Users can collect PROMs, use them to measure and analyze patient progress, and add to their collection of information that helps support their evidence-based decision making. They can capture intraoperative and implant data through barcode scanning, which then registers the data in an implant product code library that allows quick identification of patients with a specific implant in the event of a product recall. Ortech also allows automatic generation of customized operative reports on data entered from the operating room and populated into the EMR. Ortech offers 2 versions of its data collection platform, phiDB and phiDB Lite. The phiDB Lite version is for smaller practices and focuses mainly on PROMs but lacks many of the other features that phiDB offers, such as operating room modules, automated operative reports, barcode scanning, and unlimited data reporting.

Socrates

Socrates (Standardised Orthopaedic Clinical Research and Treatment Evaluation Software; Ortholink) is dedicated orthopedic software that facilitates following patient outcomes and conducting high-quality research.¹⁷ Socrates is fully customizable to fit each user’s needs. It allows for tracking of outcome scores, intraoperative details, nonoperative procedures, clinical examinations, therapies, and adverse effects. Users can also create reports from this information, which is inputted to Socrates and can be exported into EMR. Socrates data are stored on the user’s server, on site; the software generates patient summaries, collective summaries, and follow-up reports through its built-in descriptive statistics module. Raw data can be extracted for statistical analysis. Socrates can catalogue images, radiographs, documents, and videos.

Surgical Outcomes System

Surgical Outcomes System (SOS; Arthrex) is a cloud-based orthopedic and sports medicine global registry that focuses on monitoring and evaluating the outcomes of various orthopedic and sports medicine surgical procedures, as well as nonoperative interventions, to contribute to evidence-based protocols for patient treatment.¹⁸ SOS can be fully customized with desired PROMs for arthroplasty and for surgical procedures for extremity joints and even the spine. SOS includes real-time reporting on PROs for individual patients, summary PROMs for all of the physician’s patients who are receiving the same treatment, and comparisons with all registry patients (from global de-identified registry data) who had the same treatment or surgery. This real-time analysis provides immediate patient and physician feedback on treatments and products used. A patient portal for education on surgical procedures is also available. SOS is approved for use in 21 countries and is a benefit included with Arthroscopy Association of North America (AANA) membership. SOS is listed on the National Quality Registry Network (NQRN) website and, as a specialized registry as defined by CMS, can accept data generated by EMR technology.

Discussion

Delaunay¹⁹ indicated that successful registry management depends on several factors, including “use of a single identifier for each patient to ensure full traceability of all procedures related to a given implant; a long-term funding source; a contemporary, rapid, Internet-based data collection method; and the collection of exhaustive data, at least for innovative implants.” The registry systems reviewed in this article are Internet based and allow healthcare providers to monitor the clinical outcomes of their patients in the hope of improving clinical decision-making and overall patient care. From the provider perspective, many registry systems allow for integration of outcome data reporting into EMRs, including generation of operative reports. In turn, registries can improve documentation efficiency, as it was estimated that a US physician without a registry spends more than 15 hours a week reporting quality measures,20 or almost 800 hours and $15 billion each year.^20,21 It remains to be seen whether registry systems will optimize the documentation process, but there is potential improvement in time and cost-efficiency with registry use.

Although the factors involved in management are important, clinical data registries must have systems in place to help ensure patient adherence and minimize selection bias, as adherence is crucial in data accuracy.³ What helps with adherence is the ability to send automated email or SMS text message reminders to patients. According to a review, email reminders increased the completion of PROM datasets by 26%.²² When the new national quality register (NQR) HAKIR (Handkirurgiskt kvalitetsregister) was established in Sweden, it was found that when only 1 type of reminder was used (SMS text message, in this case), only about 30% of participants completed their questionnaires.²³ However, after the system was changed to send both SMS text message and email reminders, the response rate increased from 50% to 60%. Using 2 types of automated reminders might minimize lost data more effectively than 1 type alone.

Another benefit of outcome monitoring through a registry is potential reduction of interviewer- related errors. Interviewer bias can occur in many different ways. Interviewers might not follow the same instructions or administer questionnaires or surveys the same way for different patients,²⁴ the interviewer’s presence might cause the patient to alter responses based on social norms,²⁵ and the patient might report better outcomes in the presence of a physician or interviewer.^26,27 Given that clinical registries allow electronic capture of self-administered surveys, interviewer bias is reduced because all patients receive a standardized set of questions and instructions. In addition, electronic questionnaires and surveys prompt users to add or fix missed or incorrectly completed items, further reducing potential data inaccuracies.

Healthcare costs continue to rise in the United States. In 2015, the total cost of healthcare expenditure in the United States was $3.2 trillion, or almost 18% of the US gross domestic product.²⁸ In addition, in the first half of 2016, an estimated 16.2% of people under age 65 years were in families that were struggling to pay medical bills.^29,30 Healthcare reform provides a financial incentive to healthcare providers to collaborate to reduce unnecessary costs and procedures and improve the quality of healthcare.³¹ Porter and Teisberg³² defined value as health outcomes achieved per dollar spent. Registry monitoring of PROMs, which are the numerator in this critical value formula, allows providers to track patient outcomes over time to determine which interventions produce the best outcomes.²² Therefore, clinical registries play an important role in improving health outcomes and reducing the cost of healthcare.⁷

Since the Swedish Knee Arthroplasty Register (SKAR) was established 40 years ago, NQRs have been commonplace in Scandinavian countries, Australia, and the United Kingdom.²³ Between 2001 and 2014, the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) documented a decline in the financial burden of hip and knee arthroplasty revision in Australia—in comparison with the United States, which did not have a full national registry at the time and showed a revision rate increase.²⁴ The economic benefit of reducing hip and knee arthroplasty revisions in Australia during that period was an estimated $65 million to $143 million.²⁴ Besides having financial benefits, national registries allow early identification of flawed implantation products and methods, leading to a further reduction in the burden associated with recall and future use of such defective implants—including patient harm.

In addition to monitoring existing techniques and devices, registries can also follow new techniques and, compared with publication in clinical journals, more expeditiously provide clinical data for outcome expectations and treatment methods. This timeliness is particularly valuable given that publication of clinical trials with the usual mandatory 2-year follow-up can take 4 years or longer.^33,34 For instance, in the expanding field of hip arthroscopy, data from registries in both Sweden and Denmark are being analyzed.^35,36 These data are important in new fields such as hip arthroscopy, in which clinical indications and treatment techniques may vary considerably between locations.³⁵ In 2012, the Danish Hip Arthroscopy Registry (DHAR) was started as a web-based prospective registry.³⁶ Between 2012 and December 2014, DHAR added 2000 procedures, which included all hip arthroscopy procedures performed at 11 centers in Denmark.³⁶ DHAR tracks PROM, surgical procedure, operative, and radiologic data.

Increased use of clinical registries has led to use of their data in clinical research. Registry-based randomized controlled trials (RCTs) are lower in cost than other types of research, allow for rapid enrollment of patients, offer larger population sizes and multi-institutional sampling, and can provide a more diverse patient population.^19,37 Although nonregistry RCTs remain the gold standard of clinical research, registry RCTs have several advantages given the abilities and structure of registries. Because of resources and cost, nonregistry RCTs are usually limited in the number of examined exposures and typically focus on only 2.6 Registry RCTs, on the other hand, can monitor multiple exposures, typically at minimal cost difference.⁶ Another disadvantage of nonregistry RCTs is that they are often performed at institutions providing care that might not be indicative of the quality most patients expect, as these institutions might be selected for a specific clinician or specialty service.

Registry RCTs also have their limitations with respect to clinical research. A major one is their lack of validity standards or accepted benchmarks for accuracy, adherence rates, registry completeness, and data collection.^37,38 In addition, lack of standardization across national and international registries could produce conflicting data. Another limitation is that data in most registries are not subjected to any third-party checks or independent auditing.^9,39 Furthermore, evaluating the impact of registries is difficult because it is difficult to find comparable outcome data on nonregistry patients.⁴⁰ A final limitation involves the ethics of including registry data in RCTs. Although data are often added to a registry without patient consent, should the same data be used for research without patient consent? Should patients be able to disallow use of their data for research, or require a notification each time their data are used? These issues must be addressed.

Review Limitations 

One limitation of this review of clinical Internet-based outcome systems is that it might not have identified comparable systems. In addition, specific costs associated with each system were not addressed, as they depend on PROM licensing fees, total institutional access, other proprietary costs, and other variables. Another limitation, in terms of creating a national or international registry, continues to be Internet access. The Pew Research Center estimated that 84% of US adults used the Internet in 2015.⁴¹ Although 84% represents most of the adult population, the other 16% typically is over age 65 years, where only 58% of adults reported using the Internet, or come from lower income households, where access was <75%. For registries in European countries and North America, where Internet usage typically is >70%, this is not a significant problem. However, worldwide, only 47% of the population used the Internet in 2016.⁴² Internet usage by Asian and Arab states citizens was 41.6% and 41.9%, respectively, and usage by African citizens was only 25.1%. As a significant benefit of registry use is that researchers can obtain larger sample sizes, it is a problem that some populations—elderly people, people of lower socioeconomic standing, people living where the Internet is unavailable—might be underrepresented in registry data.

As mentioned, patient adherence is an ongoing issue for clinical registries. As adherence tends to decrease as more time passes after a patient’s treatment date, it is important to account for and encourage continued patient participation with outcome monitoring. Missing data lessen the validity and accuracy of a registry, increasing the likelihood that certain groups will be underrepresented. Although registry systems can reduce the cost of following PROMs, doing so requires monitoring and following up on issues of patient adherence. In other words, many clinicians will need the help of a research assistant. Makhni and colleagues²¹ found that adding a research assistant for this task increased survey adherence from 65% to 94% before surgery, from 65% to 72% 6 months after surgery, and from 38% to 56% 12 months after surgery.

Even though studies continue to use clinical data from registries, there is not much research on the impact of these registries on improvement in healthcare. Again, many factors are involved: lack of standardized benchmarks for accuracy and adherence, lack of an accepted method of data auditing and validation, and difficulty evaluating the impact of registries owing to the difficulty obtaining comparable data on nonregistry patients. Registries must adopt accepted forms of standardization in order to allow better comparisons of registries, because comparing data across registries can be useful in determining the strengths and weaknesses of different registries.^27,43 As registries support decision making at clinical, institutional, and governmental levels, it is vital that their clinical data be accurate and reliable.³⁸

Conclusion

Rising healthcare costs, and government and third-party pressures are making patient outcomes collection a standard of care. Going forward, orthopedic surgeons must be proactive, and Internet -based registries provide technological advances that facilitate the process.

Take-Home Points

• PRO data collection can provide feedback for improvements in patient care and physician performance.
• Many options exist for orthopedic physicians to establish clinical data registries.
• Registry systems can help improve patient follow-up with system monitoring and patient reminders.
• Clinical registries can offer many advantages to observational research.
• With registry use becoming more prevalent, work needs to be done to establish standards for validity and reliability.

In a 2012 review of database tools, Lubowitz and Smith¹ examined Internet-based applications that arthroscopic surgeons could use to record and monitor patient-reported outcome (PRO) data and potential adverse effects. In this article, we update orthopedic surgeons on the registries and monitoring software mentioned in that earlier publication and in other publications that have since become available.

Most orthopedic surgery candidates are seeking pain relief and improved function. Many patients expect their pain to be completely relieved by surgical intervention and their function to return to what it was before they became stricken.^2,3 Therefore, PRO measures (PROMs) are now standard in post-orthopedic surgery outcome reporting.⁴ PROMs, which include any measurement that assesses a patient’s health, illness, or benefits from the perspective of the patient, are often administered as a questionnaire or survey.⁵ The collection of PROMs continues to increase and evolve, creating a need for data storage and analysis. Registries, large collections of patient information and outcomes, allow for evaluation of patient outcomes, monitoring of adverse effects, identification of procedure incidence, understanding of predictors of prognosis, generation of feedback for quality of care, monitoring of the safety of implantable devices, and the conducting of hypothesis-driven scientific research.^6-9

Orthopedic surgery has registries at regional, national, and international levels. Although the United States has fallen well behind other countries in establishing a national registry,⁹ it has made some recent progress. The United States now has several national registries, including the American Joint Replacement Registry (AJRR), Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), the Kaiser Permanente National Total Joint Replacement Registry (TJRR), the Veterans Affairs (VA) and American College of Surgeons (ACS) National Surgical Quality Improvement Programs (NSQIPs), and the National Trauma Data Bank (NTDB).⁹ AJRR currently has 960 hospitals participating and is tracking 1,084,664 hip and knee replacements.¹⁰

These orthopedic registries, however, are limited in 2 ways. First, the majority are joint replacement registries. Second, though registries are established to determine patterns of care and predict patient outcomes, many are not set up to report care data back to healthcare providers.⁷ For procedures other than joint arthroplasty and for providers interested in tracking their patients’ PROs, systems are available for establishing clinical quality registries in orthopedics.

Registry Systems

CareSense

CareSense (Medtrak) is an Internet-based care management and data collection system designed for patient engagement, which results in fewer missed appointments, increased patient adherence, enhanced patient education, and improved patient satisfaction.¹¹ CareSense features email/text reminders for data entry, custom and standard reports, import and export of electronic medical record (EMR) information, and tools for running research studies.¹² CareSense emphasizes care navigation by helping hospitals educate and guide patients through their care by sending exercise videos to patients for home rehabilitation, transferring messages from post-acute care facilities to surgeons and caregivers, and alerting the care team to any potential readmission symptoms.^11,13 CareSense is also a Centers for Medicare & Medicaid Services (CMS) approved qualified clinical data registry (QCDR). QCDRs collect data for Merit-Based Incentive Payment System (MIPS) clinicians and submit the data to CMS.¹²

KareOutcomes

KareOutcomes, a healthcare technology and support firm founded in 2009, advocates transparency and trust among providers and patients, and aims to optimize PROs.¹⁴ The KareOutcomes team incorporates patient follow-up personnel, administrators, engineers, physicians, software developers, and technicians. The KareOutcomes software, which is backed by a 6-month guarantee, includes system design and implementation, data collection and entry, methods of submitting data to statewide or nationwide registries and sending standardized and customized surveys, and accessible and meaningful data presentation. KareOutcomes allows patient follow-up through automated reminders by telephone, SMS text message, and email. Patients can respond to surveys or questionnaires whichever way is most convenient—by telephone, Internet, SMS text message, or on paper, either in the office or by mail.

Oberd

Oberd (Universal Research Solutions) offers a comprehensive package of solutions for collecting optimal PRO data. The package has several modules: outcomes, education, registry, operative notes, data import and export, and data reporting.¹⁵ Oberd Outcomes allows convenient and engaging data collection. For example, users can send both standardized and customized forms. Oberd Education allows patients to receive information in an interactive, narrated format that is specific to their physician’s techniques and practices. Oberd Registry allows users to input multiple datasets into a registry, compare data, and generate reports with visuals. Like CareSense, Oberd is a CMS-approved QCDR. Oberd’s MIPS Dashboard helps providers collect and report patients’ reported outcomes, and use that information to modify and improve their practice.

Ortech

Ortech is a web-based data registry system that allows physicians and administrators to mine the data they own, track key metrics in their data, and improve reporting.¹⁶ Users can collect PROMs, use them to measure and analyze patient progress, and add to their collection of information that helps support their evidence-based decision making. They can capture intraoperative and implant data through barcode scanning, which then registers the data in an implant product code library that allows quick identification of patients with a specific implant in the event of a product recall. Ortech also allows automatic generation of customized operative reports on data entered from the operating room and populated into the EMR. Ortech offers 2 versions of its data collection platform, phiDB and phiDB Lite. The phiDB Lite version is for smaller practices and focuses mainly on PROMs but lacks many of the other features that phiDB offers, such as operating room modules, automated operative reports, barcode scanning, and unlimited data reporting.

Socrates

Socrates (Standardised Orthopaedic Clinical Research and Treatment Evaluation Software; Ortholink) is dedicated orthopedic software that facilitates following patient outcomes and conducting high-quality research.¹⁷ Socrates is fully customizable to fit each user’s needs. It allows for tracking of outcome scores, intraoperative details, nonoperative procedures, clinical examinations, therapies, and adverse effects. Users can also create reports from this information, which is inputted to Socrates and can be exported into EMR. Socrates data are stored on the user’s server, on site; the software generates patient summaries, collective summaries, and follow-up reports through its built-in descriptive statistics module. Raw data can be extracted for statistical analysis. Socrates can catalogue images, radiographs, documents, and videos.

Surgical Outcomes System

Surgical Outcomes System (SOS; Arthrex) is a cloud-based orthopedic and sports medicine global registry that focuses on monitoring and evaluating the outcomes of various orthopedic and sports medicine surgical procedures, as well as nonoperative interventions, to contribute to evidence-based protocols for patient treatment.¹⁸ SOS can be fully customized with desired PROMs for arthroplasty and for surgical procedures for extremity joints and even the spine. SOS includes real-time reporting on PROs for individual patients, summary PROMs for all of the physician’s patients who are receiving the same treatment, and comparisons with all registry patients (from global de-identified registry data) who had the same treatment or surgery. This real-time analysis provides immediate patient and physician feedback on treatments and products used. A patient portal for education on surgical procedures is also available. SOS is approved for use in 21 countries and is a benefit included with Arthroscopy Association of North America (AANA) membership. SOS is listed on the National Quality Registry Network (NQRN) website and, as a specialized registry as defined by CMS, can accept data generated by EMR technology.

Discussion

Delaunay¹⁹ indicated that successful registry management depends on several factors, including “use of a single identifier for each patient to ensure full traceability of all procedures related to a given implant; a long-term funding source; a contemporary, rapid, Internet-based data collection method; and the collection of exhaustive data, at least for innovative implants.” The registry systems reviewed in this article are Internet based and allow healthcare providers to monitor the clinical outcomes of their patients in the hope of improving clinical decision-making and overall patient care. From the provider perspective, many registry systems allow for integration of outcome data reporting into EMRs, including generation of operative reports. In turn, registries can improve documentation efficiency, as it was estimated that a US physician without a registry spends more than 15 hours a week reporting quality measures,20 or almost 800 hours and $15 billion each year.^20,21 It remains to be seen whether registry systems will optimize the documentation process, but there is potential improvement in time and cost-efficiency with registry use.

Although the factors involved in management are important, clinical data registries must have systems in place to help ensure patient adherence and minimize selection bias, as adherence is crucial in data accuracy.³ What helps with adherence is the ability to send automated email or SMS text message reminders to patients. According to a review, email reminders increased the completion of PROM datasets by 26%.²² When the new national quality register (NQR) HAKIR (Handkirurgiskt kvalitetsregister) was established in Sweden, it was found that when only 1 type of reminder was used (SMS text message, in this case), only about 30% of participants completed their questionnaires.²³ However, after the system was changed to send both SMS text message and email reminders, the response rate increased from 50% to 60%. Using 2 types of automated reminders might minimize lost data more effectively than 1 type alone.

Another benefit of outcome monitoring through a registry is potential reduction of interviewer- related errors. Interviewer bias can occur in many different ways. Interviewers might not follow the same instructions or administer questionnaires or surveys the same way for different patients,²⁴ the interviewer’s presence might cause the patient to alter responses based on social norms,²⁵ and the patient might report better outcomes in the presence of a physician or interviewer.^26,27 Given that clinical registries allow electronic capture of self-administered surveys, interviewer bias is reduced because all patients receive a standardized set of questions and instructions. In addition, electronic questionnaires and surveys prompt users to add or fix missed or incorrectly completed items, further reducing potential data inaccuracies.

Healthcare costs continue to rise in the United States. In 2015, the total cost of healthcare expenditure in the United States was $3.2 trillion, or almost 18% of the US gross domestic product.²⁸ In addition, in the first half of 2016, an estimated 16.2% of people under age 65 years were in families that were struggling to pay medical bills.^29,30 Healthcare reform provides a financial incentive to healthcare providers to collaborate to reduce unnecessary costs and procedures and improve the quality of healthcare.³¹ Porter and Teisberg³² defined value as health outcomes achieved per dollar spent. Registry monitoring of PROMs, which are the numerator in this critical value formula, allows providers to track patient outcomes over time to determine which interventions produce the best outcomes.²² Therefore, clinical registries play an important role in improving health outcomes and reducing the cost of healthcare.⁷

Since the Swedish Knee Arthroplasty Register (SKAR) was established 40 years ago, NQRs have been commonplace in Scandinavian countries, Australia, and the United Kingdom.²³ Between 2001 and 2014, the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) documented a decline in the financial burden of hip and knee arthroplasty revision in Australia—in comparison with the United States, which did not have a full national registry at the time and showed a revision rate increase.²⁴ The economic benefit of reducing hip and knee arthroplasty revisions in Australia during that period was an estimated $65 million to $143 million.²⁴ Besides having financial benefits, national registries allow early identification of flawed implantation products and methods, leading to a further reduction in the burden associated with recall and future use of such defective implants—including patient harm.

In addition to monitoring existing techniques and devices, registries can also follow new techniques and, compared with publication in clinical journals, more expeditiously provide clinical data for outcome expectations and treatment methods. This timeliness is particularly valuable given that publication of clinical trials with the usual mandatory 2-year follow-up can take 4 years or longer.^33,34 For instance, in the expanding field of hip arthroscopy, data from registries in both Sweden and Denmark are being analyzed.^35,36 These data are important in new fields such as hip arthroscopy, in which clinical indications and treatment techniques may vary considerably between locations.³⁵ In 2012, the Danish Hip Arthroscopy Registry (DHAR) was started as a web-based prospective registry.³⁶ Between 2012 and December 2014, DHAR added 2000 procedures, which included all hip arthroscopy procedures performed at 11 centers in Denmark.³⁶ DHAR tracks PROM, surgical procedure, operative, and radiologic data.

Increased use of clinical registries has led to use of their data in clinical research. Registry-based randomized controlled trials (RCTs) are lower in cost than other types of research, allow for rapid enrollment of patients, offer larger population sizes and multi-institutional sampling, and can provide a more diverse patient population.^19,37 Although nonregistry RCTs remain the gold standard of clinical research, registry RCTs have several advantages given the abilities and structure of registries. Because of resources and cost, nonregistry RCTs are usually limited in the number of examined exposures and typically focus on only 2.6 Registry RCTs, on the other hand, can monitor multiple exposures, typically at minimal cost difference.⁶ Another disadvantage of nonregistry RCTs is that they are often performed at institutions providing care that might not be indicative of the quality most patients expect, as these institutions might be selected for a specific clinician or specialty service.

Registry RCTs also have their limitations with respect to clinical research. A major one is their lack of validity standards or accepted benchmarks for accuracy, adherence rates, registry completeness, and data collection.^37,38 In addition, lack of standardization across national and international registries could produce conflicting data. Another limitation is that data in most registries are not subjected to any third-party checks or independent auditing.^9,39 Furthermore, evaluating the impact of registries is difficult because it is difficult to find comparable outcome data on nonregistry patients.⁴⁰ A final limitation involves the ethics of including registry data in RCTs. Although data are often added to a registry without patient consent, should the same data be used for research without patient consent? Should patients be able to disallow use of their data for research, or require a notification each time their data are used? These issues must be addressed.

Review Limitations 

One limitation of this review of clinical Internet-based outcome systems is that it might not have identified comparable systems. In addition, specific costs associated with each system were not addressed, as they depend on PROM licensing fees, total institutional access, other proprietary costs, and other variables. Another limitation, in terms of creating a national or international registry, continues to be Internet access. The Pew Research Center estimated that 84% of US adults used the Internet in 2015.⁴¹ Although 84% represents most of the adult population, the other 16% typically is over age 65 years, where only 58% of adults reported using the Internet, or come from lower income households, where access was <75%. For registries in European countries and North America, where Internet usage typically is >70%, this is not a significant problem. However, worldwide, only 47% of the population used the Internet in 2016.⁴² Internet usage by Asian and Arab states citizens was 41.6% and 41.9%, respectively, and usage by African citizens was only 25.1%. As a significant benefit of registry use is that researchers can obtain larger sample sizes, it is a problem that some populations—elderly people, people of lower socioeconomic standing, people living where the Internet is unavailable—might be underrepresented in registry data.

As mentioned, patient adherence is an ongoing issue for clinical registries. As adherence tends to decrease as more time passes after a patient’s treatment date, it is important to account for and encourage continued patient participation with outcome monitoring. Missing data lessen the validity and accuracy of a registry, increasing the likelihood that certain groups will be underrepresented. Although registry systems can reduce the cost of following PROMs, doing so requires monitoring and following up on issues of patient adherence. In other words, many clinicians will need the help of a research assistant. Makhni and colleagues²¹ found that adding a research assistant for this task increased survey adherence from 65% to 94% before surgery, from 65% to 72% 6 months after surgery, and from 38% to 56% 12 months after surgery.

Even though studies continue to use clinical data from registries, there is not much research on the impact of these registries on improvement in healthcare. Again, many factors are involved: lack of standardized benchmarks for accuracy and adherence, lack of an accepted method of data auditing and validation, and difficulty evaluating the impact of registries owing to the difficulty obtaining comparable data on nonregistry patients. Registries must adopt accepted forms of standardization in order to allow better comparisons of registries, because comparing data across registries can be useful in determining the strengths and weaknesses of different registries.^27,43 As registries support decision making at clinical, institutional, and governmental levels, it is vital that their clinical data be accurate and reliable.³⁸

Conclusion

Rising healthcare costs, and government and third-party pressures are making patient outcomes collection a standard of care. Going forward, orthopedic surgeons must be proactive, and Internet -based registries provide technological advances that facilitate the process.

Take-Home Points

• PRO data collection can provide feedback for improvements in patient care and physician performance.
• Many options exist for orthopedic physicians to establish clinical data registries.
• Registry systems can help improve patient follow-up with system monitoring and patient reminders.
• Clinical registries can offer many advantages to observational research.
• With registry use becoming more prevalent, work needs to be done to establish standards for validity and reliability.

In a 2012 review of database tools, Lubowitz and Smith¹ examined Internet-based applications that arthroscopic surgeons could use to record and monitor patient-reported outcome (PRO) data and potential adverse effects. In this article, we update orthopedic surgeons on the registries and monitoring software mentioned in that earlier publication and in other publications that have since become available.

Most orthopedic surgery candidates are seeking pain relief and improved function. Many patients expect their pain to be completely relieved by surgical intervention and their function to return to what it was before they became stricken.^2,3 Therefore, PRO measures (PROMs) are now standard in post-orthopedic surgery outcome reporting.⁴ PROMs, which include any measurement that assesses a patient’s health, illness, or benefits from the perspective of the patient, are often administered as a questionnaire or survey.⁵ The collection of PROMs continues to increase and evolve, creating a need for data storage and analysis. Registries, large collections of patient information and outcomes, allow for evaluation of patient outcomes, monitoring of adverse effects, identification of procedure incidence, understanding of predictors of prognosis, generation of feedback for quality of care, monitoring of the safety of implantable devices, and the conducting of hypothesis-driven scientific research.^6-9

Orthopedic surgery has registries at regional, national, and international levels. Although the United States has fallen well behind other countries in establishing a national registry,⁹ it has made some recent progress. The United States now has several national registries, including the American Joint Replacement Registry (AJRR), Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), the Kaiser Permanente National Total Joint Replacement Registry (TJRR), the Veterans Affairs (VA) and American College of Surgeons (ACS) National Surgical Quality Improvement Programs (NSQIPs), and the National Trauma Data Bank (NTDB).⁹ AJRR currently has 960 hospitals participating and is tracking 1,084,664 hip and knee replacements.¹⁰

These orthopedic registries, however, are limited in 2 ways. First, the majority are joint replacement registries. Second, though registries are established to determine patterns of care and predict patient outcomes, many are not set up to report care data back to healthcare providers.⁷ For procedures other than joint arthroplasty and for providers interested in tracking their patients’ PROs, systems are available for establishing clinical quality registries in orthopedics.

Registry Systems

CareSense

CareSense (Medtrak) is an Internet-based care management and data collection system designed for patient engagement, which results in fewer missed appointments, increased patient adherence, enhanced patient education, and improved patient satisfaction.¹¹ CareSense features email/text reminders for data entry, custom and standard reports, import and export of electronic medical record (EMR) information, and tools for running research studies.¹² CareSense emphasizes care navigation by helping hospitals educate and guide patients through their care by sending exercise videos to patients for home rehabilitation, transferring messages from post-acute care facilities to surgeons and caregivers, and alerting the care team to any potential readmission symptoms.^11,13 CareSense is also a Centers for Medicare & Medicaid Services (CMS) approved qualified clinical data registry (QCDR). QCDRs collect data for Merit-Based Incentive Payment System (MIPS) clinicians and submit the data to CMS.¹²

KareOutcomes

KareOutcomes, a healthcare technology and support firm founded in 2009, advocates transparency and trust among providers and patients, and aims to optimize PROs.¹⁴ The KareOutcomes team incorporates patient follow-up personnel, administrators, engineers, physicians, software developers, and technicians. The KareOutcomes software, which is backed by a 6-month guarantee, includes system design and implementation, data collection and entry, methods of submitting data to statewide or nationwide registries and sending standardized and customized surveys, and accessible and meaningful data presentation. KareOutcomes allows patient follow-up through automated reminders by telephone, SMS text message, and email. Patients can respond to surveys or questionnaires whichever way is most convenient—by telephone, Internet, SMS text message, or on paper, either in the office or by mail.

Oberd

Oberd (Universal Research Solutions) offers a comprehensive package of solutions for collecting optimal PRO data. The package has several modules: outcomes, education, registry, operative notes, data import and export, and data reporting.¹⁵ Oberd Outcomes allows convenient and engaging data collection. For example, users can send both standardized and customized forms. Oberd Education allows patients to receive information in an interactive, narrated format that is specific to their physician’s techniques and practices. Oberd Registry allows users to input multiple datasets into a registry, compare data, and generate reports with visuals. Like CareSense, Oberd is a CMS-approved QCDR. Oberd’s MIPS Dashboard helps providers collect and report patients’ reported outcomes, and use that information to modify and improve their practice.

Ortech

Ortech is a web-based data registry system that allows physicians and administrators to mine the data they own, track key metrics in their data, and improve reporting.¹⁶ Users can collect PROMs, use them to measure and analyze patient progress, and add to their collection of information that helps support their evidence-based decision making. They can capture intraoperative and implant data through barcode scanning, which then registers the data in an implant product code library that allows quick identification of patients with a specific implant in the event of a product recall. Ortech also allows automatic generation of customized operative reports on data entered from the operating room and populated into the EMR. Ortech offers 2 versions of its data collection platform, phiDB and phiDB Lite. The phiDB Lite version is for smaller practices and focuses mainly on PROMs but lacks many of the other features that phiDB offers, such as operating room modules, automated operative reports, barcode scanning, and unlimited data reporting.

Socrates

Socrates (Standardised Orthopaedic Clinical Research and Treatment Evaluation Software; Ortholink) is dedicated orthopedic software that facilitates following patient outcomes and conducting high-quality research.¹⁷ Socrates is fully customizable to fit each user’s needs. It allows for tracking of outcome scores, intraoperative details, nonoperative procedures, clinical examinations, therapies, and adverse effects. Users can also create reports from this information, which is inputted to Socrates and can be exported into EMR. Socrates data are stored on the user’s server, on site; the software generates patient summaries, collective summaries, and follow-up reports through its built-in descriptive statistics module. Raw data can be extracted for statistical analysis. Socrates can catalogue images, radiographs, documents, and videos.

Surgical Outcomes System

Surgical Outcomes System (SOS; Arthrex) is a cloud-based orthopedic and sports medicine global registry that focuses on monitoring and evaluating the outcomes of various orthopedic and sports medicine surgical procedures, as well as nonoperative interventions, to contribute to evidence-based protocols for patient treatment.¹⁸ SOS can be fully customized with desired PROMs for arthroplasty and for surgical procedures for extremity joints and even the spine. SOS includes real-time reporting on PROs for individual patients, summary PROMs for all of the physician’s patients who are receiving the same treatment, and comparisons with all registry patients (from global de-identified registry data) who had the same treatment or surgery. This real-time analysis provides immediate patient and physician feedback on treatments and products used. A patient portal for education on surgical procedures is also available. SOS is approved for use in 21 countries and is a benefit included with Arthroscopy Association of North America (AANA) membership. SOS is listed on the National Quality Registry Network (NQRN) website and, as a specialized registry as defined by CMS, can accept data generated by EMR technology.

Discussion

Delaunay¹⁹ indicated that successful registry management depends on several factors, including “use of a single identifier for each patient to ensure full traceability of all procedures related to a given implant; a long-term funding source; a contemporary, rapid, Internet-based data collection method; and the collection of exhaustive data, at least for innovative implants.” The registry systems reviewed in this article are Internet based and allow healthcare providers to monitor the clinical outcomes of their patients in the hope of improving clinical decision-making and overall patient care. From the provider perspective, many registry systems allow for integration of outcome data reporting into EMRs, including generation of operative reports. In turn, registries can improve documentation efficiency, as it was estimated that a US physician without a registry spends more than 15 hours a week reporting quality measures,20 or almost 800 hours and $15 billion each year.^20,21 It remains to be seen whether registry systems will optimize the documentation process, but there is potential improvement in time and cost-efficiency with registry use.

Although the factors involved in management are important, clinical data registries must have systems in place to help ensure patient adherence and minimize selection bias, as adherence is crucial in data accuracy.³ What helps with adherence is the ability to send automated email or SMS text message reminders to patients. According to a review, email reminders increased the completion of PROM datasets by 26%.²² When the new national quality register (NQR) HAKIR (Handkirurgiskt kvalitetsregister) was established in Sweden, it was found that when only 1 type of reminder was used (SMS text message, in this case), only about 30% of participants completed their questionnaires.²³ However, after the system was changed to send both SMS text message and email reminders, the response rate increased from 50% to 60%. Using 2 types of automated reminders might minimize lost data more effectively than 1 type alone.

Another benefit of outcome monitoring through a registry is potential reduction of interviewer- related errors. Interviewer bias can occur in many different ways. Interviewers might not follow the same instructions or administer questionnaires or surveys the same way for different patients,²⁴ the interviewer’s presence might cause the patient to alter responses based on social norms,²⁵ and the patient might report better outcomes in the presence of a physician or interviewer.^26,27 Given that clinical registries allow electronic capture of self-administered surveys, interviewer bias is reduced because all patients receive a standardized set of questions and instructions. In addition, electronic questionnaires and surveys prompt users to add or fix missed or incorrectly completed items, further reducing potential data inaccuracies.

Healthcare costs continue to rise in the United States. In 2015, the total cost of healthcare expenditure in the United States was $3.2 trillion, or almost 18% of the US gross domestic product.²⁸ In addition, in the first half of 2016, an estimated 16.2% of people under age 65 years were in families that were struggling to pay medical bills.^29,30 Healthcare reform provides a financial incentive to healthcare providers to collaborate to reduce unnecessary costs and procedures and improve the quality of healthcare.³¹ Porter and Teisberg³² defined value as health outcomes achieved per dollar spent. Registry monitoring of PROMs, which are the numerator in this critical value formula, allows providers to track patient outcomes over time to determine which interventions produce the best outcomes.²² Therefore, clinical registries play an important role in improving health outcomes and reducing the cost of healthcare.⁷

Since the Swedish Knee Arthroplasty Register (SKAR) was established 40 years ago, NQRs have been commonplace in Scandinavian countries, Australia, and the United Kingdom.²³ Between 2001 and 2014, the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) documented a decline in the financial burden of hip and knee arthroplasty revision in Australia—in comparison with the United States, which did not have a full national registry at the time and showed a revision rate increase.²⁴ The economic benefit of reducing hip and knee arthroplasty revisions in Australia during that period was an estimated $65 million to $143 million.²⁴ Besides having financial benefits, national registries allow early identification of flawed implantation products and methods, leading to a further reduction in the burden associated with recall and future use of such defective implants—including patient harm.

In addition to monitoring existing techniques and devices, registries can also follow new techniques and, compared with publication in clinical journals, more expeditiously provide clinical data for outcome expectations and treatment methods. This timeliness is particularly valuable given that publication of clinical trials with the usual mandatory 2-year follow-up can take 4 years or longer.^33,34 For instance, in the expanding field of hip arthroscopy, data from registries in both Sweden and Denmark are being analyzed.^35,36 These data are important in new fields such as hip arthroscopy, in which clinical indications and treatment techniques may vary considerably between locations.³⁵ In 2012, the Danish Hip Arthroscopy Registry (DHAR) was started as a web-based prospective registry.³⁶ Between 2012 and December 2014, DHAR added 2000 procedures, which included all hip arthroscopy procedures performed at 11 centers in Denmark.³⁶ DHAR tracks PROM, surgical procedure, operative, and radiologic data.

Increased use of clinical registries has led to use of their data in clinical research. Registry-based randomized controlled trials (RCTs) are lower in cost than other types of research, allow for rapid enrollment of patients, offer larger population sizes and multi-institutional sampling, and can provide a more diverse patient population.^19,37 Although nonregistry RCTs remain the gold standard of clinical research, registry RCTs have several advantages given the abilities and structure of registries. Because of resources and cost, nonregistry RCTs are usually limited in the number of examined exposures and typically focus on only 2.6 Registry RCTs, on the other hand, can monitor multiple exposures, typically at minimal cost difference.⁶ Another disadvantage of nonregistry RCTs is that they are often performed at institutions providing care that might not be indicative of the quality most patients expect, as these institutions might be selected for a specific clinician or specialty service.

Registry RCTs also have their limitations with respect to clinical research. A major one is their lack of validity standards or accepted benchmarks for accuracy, adherence rates, registry completeness, and data collection.^37,38 In addition, lack of standardization across national and international registries could produce conflicting data. Another limitation is that data in most registries are not subjected to any third-party checks or independent auditing.^9,39 Furthermore, evaluating the impact of registries is difficult because it is difficult to find comparable outcome data on nonregistry patients.⁴⁰ A final limitation involves the ethics of including registry data in RCTs. Although data are often added to a registry without patient consent, should the same data be used for research without patient consent? Should patients be able to disallow use of their data for research, or require a notification each time their data are used? These issues must be addressed.

Review Limitations 

One limitation of this review of clinical Internet-based outcome systems is that it might not have identified comparable systems. In addition, specific costs associated with each system were not addressed, as they depend on PROM licensing fees, total institutional access, other proprietary costs, and other variables. Another limitation, in terms of creating a national or international registry, continues to be Internet access. The Pew Research Center estimated that 84% of US adults used the Internet in 2015.⁴¹ Although 84% represents most of the adult population, the other 16% typically is over age 65 years, where only 58% of adults reported using the Internet, or come from lower income households, where access was <75%. For registries in European countries and North America, where Internet usage typically is >70%, this is not a significant problem. However, worldwide, only 47% of the population used the Internet in 2016.⁴² Internet usage by Asian and Arab states citizens was 41.6% and 41.9%, respectively, and usage by African citizens was only 25.1%. As a significant benefit of registry use is that researchers can obtain larger sample sizes, it is a problem that some populations—elderly people, people of lower socioeconomic standing, people living where the Internet is unavailable—might be underrepresented in registry data.

As mentioned, patient adherence is an ongoing issue for clinical registries. As adherence tends to decrease as more time passes after a patient’s treatment date, it is important to account for and encourage continued patient participation with outcome monitoring. Missing data lessen the validity and accuracy of a registry, increasing the likelihood that certain groups will be underrepresented. Although registry systems can reduce the cost of following PROMs, doing so requires monitoring and following up on issues of patient adherence. In other words, many clinicians will need the help of a research assistant. Makhni and colleagues²¹ found that adding a research assistant for this task increased survey adherence from 65% to 94% before surgery, from 65% to 72% 6 months after surgery, and from 38% to 56% 12 months after surgery.

Even though studies continue to use clinical data from registries, there is not much research on the impact of these registries on improvement in healthcare. Again, many factors are involved: lack of standardized benchmarks for accuracy and adherence, lack of an accepted method of data auditing and validation, and difficulty evaluating the impact of registries owing to the difficulty obtaining comparable data on nonregistry patients. Registries must adopt accepted forms of standardization in order to allow better comparisons of registries, because comparing data across registries can be useful in determining the strengths and weaknesses of different registries.^27,43 As registries support decision making at clinical, institutional, and governmental levels, it is vital that their clinical data be accurate and reliable.³⁸

Conclusion

Rising healthcare costs, and government and third-party pressures are making patient outcomes collection a standard of care. Going forward, orthopedic surgeons must be proactive, and Internet -based registries provide technological advances that facilitate the process.

Take-Home Points

• Systematic use of PROMs allows physicians to review data on pain, physical function, and psychological status to aid in clinical decision-making and best practices.
• PROMs should include both general outcome measures (VAS, SF-36, or EQ-5D) and reliable, valid, and responsive disease specific measures.
• PROM questionnaires should collect pertinent information while limiting the length to maximize patient compliance and reliability.
• PROMIS has been developed to standardize questionnaires, but generality for specific orthopedic procedures may result in less effective measures.
• PROMs can also be used for predictive modeling, which has the potential to help develop more cost-effective care and predict expected outcomes and recovery trajectories for individual patients.

Owing to their unique ability to recognize patients as stakeholders in their own healthcare, patient-reported outcome measures (PROMs) are becoming increasingly popular in the assessment of medical and surgical outcomes.¹ PROMs are an outcome measures subset in which patients complete questionnaires about their perceptions of their overall health status and specific health limitations. By systematically using PROMs before and after a clearly defined episode of care, clinicians can collect data on perceived pain level, physical function, and psychological status and use the data to validate use of surgical procedures and shape clinical decisions about best practices.^2-4 Although mortality and morbidity rates and other traditional measures are valuable in assessing outcomes, they do not represent or communicate the larger impact of an episode of care. As many orthopedic procedures are elective, and some are low-risk, the evaluation of changes in quality of life and self-reported functional improvement is an important addition to morbidity and mortality rates in capturing the true impact of a surgical procedure and recovery. The patient’s preoperative and postoperative perspectives on his or her health status have become important as well; our healthcare system has been placing more emphasis on patient-centered quality care.^2,5

Although PROMs have many benefits, implementation in an orthopedic surgery practice has its challenges. With so many PROMs available, selecting those that fit the patient population for a specialized orthopedic surgery practice can be difficult. In addition, although PROM data are essential for research and for measuring individual or institutional recovery trajectories for surgical procedures, in a busy practice getting patients to provide these data can be difficult.

PROMs are heavily used for outcomes assessment in the orthopedics literature, but there are few resources for orthopedic surgeons who want to implement PROMs in their practices. In this article, we review the literature on the challenges of effectively implementing PROMs in an orthopedic surgery practice.

PROM Selection Considerations

PROMs can be categorized as either generic or disease-specific,⁴ but together they are used to adequately capture the impact, both broad and local, of an orthopedic condition.

Generic Outcome Measures

Generic outcome measures apply to a range of subspecialties or anatomical regions, allowing for evaluation of a patient’s overall health or quality of life. The most widely accepted measure of pain is the visual analog scale (VAS). The VAS for pain quantifies the level of pain a patient experiences at a given time on a graphic sliding scale from 0 (no pain) to 10 (worst possible pain). The VAS is used in clinical evaluation of pain and in reported outcomes literature.^6,7

Many generic PROMs assess mental health status in addition to physical limitations. Poor preoperative mental health status has been recognized as a predictor of worse outcomes across a variety of orthopedic procedures.^8,9 Therefore, to assess the overall influence of an orthopedic condition, it is important to include at least 1 generic PROM that assesses mental health status before and after an episode of care. Generic PROMs commonly used in orthopedic surgery include the 36-Item Short Form Health Survey (SF-36), the shorter SF-12, the Veterans RAND 12-Item Health Survey (VR-12), the World Health Organization Disability Assessment Schedule (WHODAS), the European Quality of Life-5 Dimensions (EQ-5D) index, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-10) scale.^10-14

Some generic outcome measures (eg, the EQ-5D index) offer the “utility” calculation, which represents a preference for a patient’s desired health status. Such utilities allow for a measurement of quality of life, represented by quality-adjusted life years (QALY), which is a standardized measure of disease burden. Calculated QALY from measures such as the EQ-5D can be used in cost-effectiveness analyses of surgical interventions and have been used to validate use of procedures, particularly in arthroplasty.^15-17

Disease-Specific Outcome Measures

Likewise, there is a range of disease-specific PROMs validated for use in orthopedic surgery, and providers select PROMs that fit their scope of practice. In anatomical regions such as the knee, hip, and shoulder, disease-specific outcome measures vary significantly by subspecialty and patient population. When selecting disease-specific PROMs, providers must consider tools such as reliability, validity, responsiveness, and available population norms. One study used Evaluating Measures of Patient-Reported Outcomes (EMPRO) to assess the quality of a PROM in shoulders and concluded that the American Shoulder and Elbow Surgeons (ASES) index, the Simple Shoulder Test (SST), and the Oxford Shoulder Score (OSS) were all supported for use in practice.¹⁸ It is important to note that reliability, validity, and responsiveness of a PROM may vary with the diagnosis or the patient population studied. For example, the SST was found to be responsive in assessing rotator cuff injury but not as useful in assessing shoulder instability or arthritis.¹⁹ Variable responsiveness highlights the need for a diagnosis-based level of PROM customization. For example, patients who undergo a surgical intervention for shoulder instability are given a customized survey, which includes PROMs specific to their condition, such as the Western Ontario Shoulder Instability (WOSI) index.²⁰ For patients with knee instability, similar considerations apply; specific measures such as the Lysholm score and the Tenger Activity Scale capture the impact of injury in physically demanding activities.²¹ When selecting disease-specific PROMs, providers should consult articles like those by Davidson and Keating²² and Bent and colleagues,²³ who present provider-friendly tools that can be used to examine the effectiveness of a PROM, and provide additional background information on selecting disease-specific PROMs. For hip and knee arthroplasty subspecialties, the International Society of Arthroplasty Registries (ISAR) created a working group that determines best practices for PROM collection and identifies PROMs most commonly reported in arthroplasty.²⁴

Questionnaire Length Considerations

When PROMs are used in a practice, a balance must be struck between gathering enough information to determine functionality and limiting the patient burden of questionnaire length. A decision to use several PROMs all at once, at a single data collection point, can lengthen the questionnaire significantly. One study found that, with use of longer questionnaires, patients may lose interest, resulting in decreased reliability and compliance.²⁵ For example, providers who use the long (42-item) Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire to assess knee function are often limited in what other PROMs they may administer at the same time. Efforts to shorten this questionnaire while still capturing necessary information led to the development of the 7-item KOOS Jr, which was validated for use in knee arthroplasty and had its 7 items drawn from the original 42.²⁶ Similarly, the 40-item Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire was shortened to the 6-item HOOS Jr, which was validated for use in hip arthroplasty,²⁷ and the generic SF-36 was shortened to the SF-12.¹¹ Providers trying to build an outcomes database while minimizing patient burden should consider using the shorter versions of these questionnaires but should also consider their validity, as KOOS Jr and HOOS Jr have been validated for use only in knee and hip arthroplasty and not in other knee and hip conditions.

PROM Data Collection Considerations

Comprehensive collection of longitudinal PROM data poses many challenges for providers and patients. For providers, the greatest challenges are infrastructure, technology, and the personnel needed to administer and store paper or electronic surveys. For patients, the most common survey completion barriers are questionnaire length, confusing or irrelevant content, and, in the case of some older adults, inability to complete surveys electronically.²⁵

Identifying a nonresponsive or noncompliant patient population is an important issue in collecting PROM data for research or other purposes. A study of factors associated with higher nonresponse rates in elective surgery patients (N = 135,474) found that noncompliance was higher for males, patients under age 55 years, nonwhites, patients in the lowest socioeconomic quintile, patients living alone, patients needing assistance in completing questionnaires, and patients who previously underwent surgery for their condition.²⁸ In a systematic review of methods that increased the response rates of postal and electronic surveys, Edwards and colleagues²⁹ found significantly higher odds of response for patients who were prenotified of the survey, given shorter questionnaires, or given a deadline for survey completion. Of note, response rates were lower when the word survey was used in the subject line of an email. 

PROM distribution has evolved with the rise of technological advances that allow for electronic survey distribution and data capture. Several studies have found that electronically administered PROMs have high response rates.^3,30,31 In a study of patients who underwent total hip arthroplasty, Rolfson and colleagues³² found that response rates were significantly higher for those who were surveyed on paper than for those surveyed over the internet. A randomized controlled study found that, compared with paper surveys, digital tablet surveys effectively and reliably collected PROM data; in addition, digital tablets provided instant data storage, and improved survey completion by requiring that all questions be answered before the survey could be submitted.33 However, age, race/ethnicity, and income disparities in technology use must be considered when administering internet-based follow-up surveys and analyzing data collected with web-based methods.³⁴ A study of total joint arthroplasty candidates found that several groups were less likely to complete electronic PROM questionnaires: patients over age 75 years, Hispanic or black patients, patients with Medicare or Medicaid, patients who previously underwent orthopedic surgery, patients undergoing revision total joint arthroplasty, patients with other comorbidities, and patients whose primary language was not English.³⁵ Providers interested in implementing PROMs must consider their patient population when selecting a method for survey distribution and follow-up. A study found that a majority of PROMs were written at a level many patients may not have understood, because of their literacy level or age; this lack of understanding created a barrier to compliance in many patient populations.³⁶

PROM Limitations and PROMIS Use

Use of PROMs has its limitations. The large variety of PROMs available for use in orthopedic surgery has led to several standardization initiatives. The National Institutes of Health funded the development of PROMIS, a person-centered measures database that evaluates and monitors the physical, social, and emotional health of adults and children.³⁷ The goal of PROMIS is to develop a standardized method of selecting PROMs, so that all medical disciplines and subspecialties can choose an applicable set of questions from the PROMIS question bank and use it in practice. Orthopedic surgery can use questions pertaining to physical functioning of the lower and upper extremities as well as quality of life and mental health. PROMIS physical function questions have been validated for use in several areas of orthopedic surgery.^38-40 A disadvantage of PROMIS is the overgenerality of its questions, which may not be as effective in capturing the implications of specific diagnoses. For example, it is difficult to use generalized questions to determine the implications of a diagnosis such as shoulder instability, which may affect only higher functioning activities or sports. More research on best PROM selection practices is needed in order to either standardize PROMs or move toward use of a single database such as PROMIS.

Future Directions in PROM Applications

PROMs are being used for research and patient engagement, but there are many other applications on the horizon. As already mentioned, predictive modeling is of particular interest. The existence of vast collaborative PROM databases that capture a diverse patient population introduces the possibility of creating models capable of predicting a patient outcome and enhancing shared decision-making.³ Predicting good or excellent patient outcomes for specific patient populations may allow elimination of certain postoperative visits, thereby creating more cost-effective care and reducing the burden of unnecessary clinic visits for both patients and physicians.

As with other healthcare areas, PROM data collection technology is rapidly advancing. Not only has electronic technology almost entirely replaced paper-and-pencil collection methods, but a new method of outcome data collection has been developed: computerized adaptive testing (CAT). CAT uses item-response theory to minimize the number of questions patients must answer in order for validated and reliable outcome scores to be calculated. According to multiple studies, CAT used across several questionnaires has reliably assessed PROMs while minimizing floor and ceiling effects, eliminating irrelevant questions, and shortening survey completion time.^41-43

Besides becoming more patient-friendly and accessible across multiple interfaces (mobile devices and computers), PROMs are also beginning to be integrated into the electronic medical record, allowing easier access to information during chart reviews. Use of statistical and predictive modeling, as described by Chang,³ could give PROMs a role in clinical decision-making. Informing patients of their expected outcome and recovery trajectory—based on demographics, comorbidities, preoperative functional status, and other factors—could influence their decision to undergo surgical intervention. As Halawi and colleagues⁴⁴ pointed out, it is important to discuss patient expectations before surgery, as unrealistic ones can negatively affect outcomes and lead to dissatisfaction. With clinicians having ready access to statistics and models in patient charts, we may see a transformation in clinical practices and surgical decision-making.

Conclusion

PROMs offer many ways to improve research and clinical care in orthopedic surgery. However, implementing PROMs in practice is not without challenges. Interested orthopedic surgeons should select the PROMs that are most appropriate—reliable, validated, and responsive to their patient population. Electronic distribution of PROM questionnaires is effective and allows data to be stored on entry, but orthopedic surgeons must consider their patient population to ensure accurate data capture and compliance in longitudinal surveys. Proper implementation of PROMs in a practice can allow clinicians to formulate expectations for postoperative recovery and set reasonable postoperative goals while engaging patients in improving quality of care.

Take-Home Points

• Systematic use of PROMs allows physicians to review data on pain, physical function, and psychological status to aid in clinical decision-making and best practices.
• PROMs should include both general outcome measures (VAS, SF-36, or EQ-5D) and reliable, valid, and responsive disease specific measures.
• PROM questionnaires should collect pertinent information while limiting the length to maximize patient compliance and reliability.
• PROMIS has been developed to standardize questionnaires, but generality for specific orthopedic procedures may result in less effective measures.
• PROMs can also be used for predictive modeling, which has the potential to help develop more cost-effective care and predict expected outcomes and recovery trajectories for individual patients.

Owing to their unique ability to recognize patients as stakeholders in their own healthcare, patient-reported outcome measures (PROMs) are becoming increasingly popular in the assessment of medical and surgical outcomes.¹ PROMs are an outcome measures subset in which patients complete questionnaires about their perceptions of their overall health status and specific health limitations. By systematically using PROMs before and after a clearly defined episode of care, clinicians can collect data on perceived pain level, physical function, and psychological status and use the data to validate use of surgical procedures and shape clinical decisions about best practices.^2-4 Although mortality and morbidity rates and other traditional measures are valuable in assessing outcomes, they do not represent or communicate the larger impact of an episode of care. As many orthopedic procedures are elective, and some are low-risk, the evaluation of changes in quality of life and self-reported functional improvement is an important addition to morbidity and mortality rates in capturing the true impact of a surgical procedure and recovery. The patient’s preoperative and postoperative perspectives on his or her health status have become important as well; our healthcare system has been placing more emphasis on patient-centered quality care.^2,5

Although PROMs have many benefits, implementation in an orthopedic surgery practice has its challenges. With so many PROMs available, selecting those that fit the patient population for a specialized orthopedic surgery practice can be difficult. In addition, although PROM data are essential for research and for measuring individual or institutional recovery trajectories for surgical procedures, in a busy practice getting patients to provide these data can be difficult.

PROMs are heavily used for outcomes assessment in the orthopedics literature, but there are few resources for orthopedic surgeons who want to implement PROMs in their practices. In this article, we review the literature on the challenges of effectively implementing PROMs in an orthopedic surgery practice.

PROM Selection Considerations

PROMs can be categorized as either generic or disease-specific,⁴ but together they are used to adequately capture the impact, both broad and local, of an orthopedic condition.

Generic Outcome Measures

Generic outcome measures apply to a range of subspecialties or anatomical regions, allowing for evaluation of a patient’s overall health or quality of life. The most widely accepted measure of pain is the visual analog scale (VAS). The VAS for pain quantifies the level of pain a patient experiences at a given time on a graphic sliding scale from 0 (no pain) to 10 (worst possible pain). The VAS is used in clinical evaluation of pain and in reported outcomes literature.^6,7

Many generic PROMs assess mental health status in addition to physical limitations. Poor preoperative mental health status has been recognized as a predictor of worse outcomes across a variety of orthopedic procedures.^8,9 Therefore, to assess the overall influence of an orthopedic condition, it is important to include at least 1 generic PROM that assesses mental health status before and after an episode of care. Generic PROMs commonly used in orthopedic surgery include the 36-Item Short Form Health Survey (SF-36), the shorter SF-12, the Veterans RAND 12-Item Health Survey (VR-12), the World Health Organization Disability Assessment Schedule (WHODAS), the European Quality of Life-5 Dimensions (EQ-5D) index, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-10) scale.^10-14

Some generic outcome measures (eg, the EQ-5D index) offer the “utility” calculation, which represents a preference for a patient’s desired health status. Such utilities allow for a measurement of quality of life, represented by quality-adjusted life years (QALY), which is a standardized measure of disease burden. Calculated QALY from measures such as the EQ-5D can be used in cost-effectiveness analyses of surgical interventions and have been used to validate use of procedures, particularly in arthroplasty.^15-17

Disease-Specific Outcome Measures

Likewise, there is a range of disease-specific PROMs validated for use in orthopedic surgery, and providers select PROMs that fit their scope of practice. In anatomical regions such as the knee, hip, and shoulder, disease-specific outcome measures vary significantly by subspecialty and patient population. When selecting disease-specific PROMs, providers must consider tools such as reliability, validity, responsiveness, and available population norms. One study used Evaluating Measures of Patient-Reported Outcomes (EMPRO) to assess the quality of a PROM in shoulders and concluded that the American Shoulder and Elbow Surgeons (ASES) index, the Simple Shoulder Test (SST), and the Oxford Shoulder Score (OSS) were all supported for use in practice.¹⁸ It is important to note that reliability, validity, and responsiveness of a PROM may vary with the diagnosis or the patient population studied. For example, the SST was found to be responsive in assessing rotator cuff injury but not as useful in assessing shoulder instability or arthritis.¹⁹ Variable responsiveness highlights the need for a diagnosis-based level of PROM customization. For example, patients who undergo a surgical intervention for shoulder instability are given a customized survey, which includes PROMs specific to their condition, such as the Western Ontario Shoulder Instability (WOSI) index.²⁰ For patients with knee instability, similar considerations apply; specific measures such as the Lysholm score and the Tenger Activity Scale capture the impact of injury in physically demanding activities.²¹ When selecting disease-specific PROMs, providers should consult articles like those by Davidson and Keating²² and Bent and colleagues,²³ who present provider-friendly tools that can be used to examine the effectiveness of a PROM, and provide additional background information on selecting disease-specific PROMs. For hip and knee arthroplasty subspecialties, the International Society of Arthroplasty Registries (ISAR) created a working group that determines best practices for PROM collection and identifies PROMs most commonly reported in arthroplasty.²⁴

Questionnaire Length Considerations

When PROMs are used in a practice, a balance must be struck between gathering enough information to determine functionality and limiting the patient burden of questionnaire length. A decision to use several PROMs all at once, at a single data collection point, can lengthen the questionnaire significantly. One study found that, with use of longer questionnaires, patients may lose interest, resulting in decreased reliability and compliance.²⁵ For example, providers who use the long (42-item) Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire to assess knee function are often limited in what other PROMs they may administer at the same time. Efforts to shorten this questionnaire while still capturing necessary information led to the development of the 7-item KOOS Jr, which was validated for use in knee arthroplasty and had its 7 items drawn from the original 42.²⁶ Similarly, the 40-item Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire was shortened to the 6-item HOOS Jr, which was validated for use in hip arthroplasty,²⁷ and the generic SF-36 was shortened to the SF-12.¹¹ Providers trying to build an outcomes database while minimizing patient burden should consider using the shorter versions of these questionnaires but should also consider their validity, as KOOS Jr and HOOS Jr have been validated for use only in knee and hip arthroplasty and not in other knee and hip conditions.

PROM Data Collection Considerations

Comprehensive collection of longitudinal PROM data poses many challenges for providers and patients. For providers, the greatest challenges are infrastructure, technology, and the personnel needed to administer and store paper or electronic surveys. For patients, the most common survey completion barriers are questionnaire length, confusing or irrelevant content, and, in the case of some older adults, inability to complete surveys electronically.²⁵

Identifying a nonresponsive or noncompliant patient population is an important issue in collecting PROM data for research or other purposes. A study of factors associated with higher nonresponse rates in elective surgery patients (N = 135,474) found that noncompliance was higher for males, patients under age 55 years, nonwhites, patients in the lowest socioeconomic quintile, patients living alone, patients needing assistance in completing questionnaires, and patients who previously underwent surgery for their condition.²⁸ In a systematic review of methods that increased the response rates of postal and electronic surveys, Edwards and colleagues²⁹ found significantly higher odds of response for patients who were prenotified of the survey, given shorter questionnaires, or given a deadline for survey completion. Of note, response rates were lower when the word survey was used in the subject line of an email. 

PROM distribution has evolved with the rise of technological advances that allow for electronic survey distribution and data capture. Several studies have found that electronically administered PROMs have high response rates.^3,30,31 In a study of patients who underwent total hip arthroplasty, Rolfson and colleagues³² found that response rates were significantly higher for those who were surveyed on paper than for those surveyed over the internet. A randomized controlled study found that, compared with paper surveys, digital tablet surveys effectively and reliably collected PROM data; in addition, digital tablets provided instant data storage, and improved survey completion by requiring that all questions be answered before the survey could be submitted.33 However, age, race/ethnicity, and income disparities in technology use must be considered when administering internet-based follow-up surveys and analyzing data collected with web-based methods.³⁴ A study of total joint arthroplasty candidates found that several groups were less likely to complete electronic PROM questionnaires: patients over age 75 years, Hispanic or black patients, patients with Medicare or Medicaid, patients who previously underwent orthopedic surgery, patients undergoing revision total joint arthroplasty, patients with other comorbidities, and patients whose primary language was not English.³⁵ Providers interested in implementing PROMs must consider their patient population when selecting a method for survey distribution and follow-up. A study found that a majority of PROMs were written at a level many patients may not have understood, because of their literacy level or age; this lack of understanding created a barrier to compliance in many patient populations.³⁶

PROM Limitations and PROMIS Use

Use of PROMs has its limitations. The large variety of PROMs available for use in orthopedic surgery has led to several standardization initiatives. The National Institutes of Health funded the development of PROMIS, a person-centered measures database that evaluates and monitors the physical, social, and emotional health of adults and children.³⁷ The goal of PROMIS is to develop a standardized method of selecting PROMs, so that all medical disciplines and subspecialties can choose an applicable set of questions from the PROMIS question bank and use it in practice. Orthopedic surgery can use questions pertaining to physical functioning of the lower and upper extremities as well as quality of life and mental health. PROMIS physical function questions have been validated for use in several areas of orthopedic surgery.^38-40 A disadvantage of PROMIS is the overgenerality of its questions, which may not be as effective in capturing the implications of specific diagnoses. For example, it is difficult to use generalized questions to determine the implications of a diagnosis such as shoulder instability, which may affect only higher functioning activities or sports. More research on best PROM selection practices is needed in order to either standardize PROMs or move toward use of a single database such as PROMIS.

Future Directions in PROM Applications

PROMs are being used for research and patient engagement, but there are many other applications on the horizon. As already mentioned, predictive modeling is of particular interest. The existence of vast collaborative PROM databases that capture a diverse patient population introduces the possibility of creating models capable of predicting a patient outcome and enhancing shared decision-making.³ Predicting good or excellent patient outcomes for specific patient populations may allow elimination of certain postoperative visits, thereby creating more cost-effective care and reducing the burden of unnecessary clinic visits for both patients and physicians.

As with other healthcare areas, PROM data collection technology is rapidly advancing. Not only has electronic technology almost entirely replaced paper-and-pencil collection methods, but a new method of outcome data collection has been developed: computerized adaptive testing (CAT). CAT uses item-response theory to minimize the number of questions patients must answer in order for validated and reliable outcome scores to be calculated. According to multiple studies, CAT used across several questionnaires has reliably assessed PROMs while minimizing floor and ceiling effects, eliminating irrelevant questions, and shortening survey completion time.^41-43

Besides becoming more patient-friendly and accessible across multiple interfaces (mobile devices and computers), PROMs are also beginning to be integrated into the electronic medical record, allowing easier access to information during chart reviews. Use of statistical and predictive modeling, as described by Chang,³ could give PROMs a role in clinical decision-making. Informing patients of their expected outcome and recovery trajectory—based on demographics, comorbidities, preoperative functional status, and other factors—could influence their decision to undergo surgical intervention. As Halawi and colleagues⁴⁴ pointed out, it is important to discuss patient expectations before surgery, as unrealistic ones can negatively affect outcomes and lead to dissatisfaction. With clinicians having ready access to statistics and models in patient charts, we may see a transformation in clinical practices and surgical decision-making.

Conclusion

PROMs offer many ways to improve research and clinical care in orthopedic surgery. However, implementing PROMs in practice is not without challenges. Interested orthopedic surgeons should select the PROMs that are most appropriate—reliable, validated, and responsive to their patient population. Electronic distribution of PROM questionnaires is effective and allows data to be stored on entry, but orthopedic surgeons must consider their patient population to ensure accurate data capture and compliance in longitudinal surveys. Proper implementation of PROMs in a practice can allow clinicians to formulate expectations for postoperative recovery and set reasonable postoperative goals while engaging patients in improving quality of care.

Take-Home Points

• Systematic use of PROMs allows physicians to review data on pain, physical function, and psychological status to aid in clinical decision-making and best practices.
• PROMs should include both general outcome measures (VAS, SF-36, or EQ-5D) and reliable, valid, and responsive disease specific measures.
• PROM questionnaires should collect pertinent information while limiting the length to maximize patient compliance and reliability.
• PROMIS has been developed to standardize questionnaires, but generality for specific orthopedic procedures may result in less effective measures.
• PROMs can also be used for predictive modeling, which has the potential to help develop more cost-effective care and predict expected outcomes and recovery trajectories for individual patients.

Owing to their unique ability to recognize patients as stakeholders in their own healthcare, patient-reported outcome measures (PROMs) are becoming increasingly popular in the assessment of medical and surgical outcomes.¹ PROMs are an outcome measures subset in which patients complete questionnaires about their perceptions of their overall health status and specific health limitations. By systematically using PROMs before and after a clearly defined episode of care, clinicians can collect data on perceived pain level, physical function, and psychological status and use the data to validate use of surgical procedures and shape clinical decisions about best practices.^2-4 Although mortality and morbidity rates and other traditional measures are valuable in assessing outcomes, they do not represent or communicate the larger impact of an episode of care. As many orthopedic procedures are elective, and some are low-risk, the evaluation of changes in quality of life and self-reported functional improvement is an important addition to morbidity and mortality rates in capturing the true impact of a surgical procedure and recovery. The patient’s preoperative and postoperative perspectives on his or her health status have become important as well; our healthcare system has been placing more emphasis on patient-centered quality care.^2,5

Although PROMs have many benefits, implementation in an orthopedic surgery practice has its challenges. With so many PROMs available, selecting those that fit the patient population for a specialized orthopedic surgery practice can be difficult. In addition, although PROM data are essential for research and for measuring individual or institutional recovery trajectories for surgical procedures, in a busy practice getting patients to provide these data can be difficult.

PROMs are heavily used for outcomes assessment in the orthopedics literature, but there are few resources for orthopedic surgeons who want to implement PROMs in their practices. In this article, we review the literature on the challenges of effectively implementing PROMs in an orthopedic surgery practice.

PROM Selection Considerations

PROMs can be categorized as either generic or disease-specific,⁴ but together they are used to adequately capture the impact, both broad and local, of an orthopedic condition.

Generic Outcome Measures

Generic outcome measures apply to a range of subspecialties or anatomical regions, allowing for evaluation of a patient’s overall health or quality of life. The most widely accepted measure of pain is the visual analog scale (VAS). The VAS for pain quantifies the level of pain a patient experiences at a given time on a graphic sliding scale from 0 (no pain) to 10 (worst possible pain). The VAS is used in clinical evaluation of pain and in reported outcomes literature.^6,7

Many generic PROMs assess mental health status in addition to physical limitations. Poor preoperative mental health status has been recognized as a predictor of worse outcomes across a variety of orthopedic procedures.^8,9 Therefore, to assess the overall influence of an orthopedic condition, it is important to include at least 1 generic PROM that assesses mental health status before and after an episode of care. Generic PROMs commonly used in orthopedic surgery include the 36-Item Short Form Health Survey (SF-36), the shorter SF-12, the Veterans RAND 12-Item Health Survey (VR-12), the World Health Organization Disability Assessment Schedule (WHODAS), the European Quality of Life-5 Dimensions (EQ-5D) index, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-10) scale.^10-14

Some generic outcome measures (eg, the EQ-5D index) offer the “utility” calculation, which represents a preference for a patient’s desired health status. Such utilities allow for a measurement of quality of life, represented by quality-adjusted life years (QALY), which is a standardized measure of disease burden. Calculated QALY from measures such as the EQ-5D can be used in cost-effectiveness analyses of surgical interventions and have been used to validate use of procedures, particularly in arthroplasty.^15-17

Disease-Specific Outcome Measures

Likewise, there is a range of disease-specific PROMs validated for use in orthopedic surgery, and providers select PROMs that fit their scope of practice. In anatomical regions such as the knee, hip, and shoulder, disease-specific outcome measures vary significantly by subspecialty and patient population. When selecting disease-specific PROMs, providers must consider tools such as reliability, validity, responsiveness, and available population norms. One study used Evaluating Measures of Patient-Reported Outcomes (EMPRO) to assess the quality of a PROM in shoulders and concluded that the American Shoulder and Elbow Surgeons (ASES) index, the Simple Shoulder Test (SST), and the Oxford Shoulder Score (OSS) were all supported for use in practice.¹⁸ It is important to note that reliability, validity, and responsiveness of a PROM may vary with the diagnosis or the patient population studied. For example, the SST was found to be responsive in assessing rotator cuff injury but not as useful in assessing shoulder instability or arthritis.¹⁹ Variable responsiveness highlights the need for a diagnosis-based level of PROM customization. For example, patients who undergo a surgical intervention for shoulder instability are given a customized survey, which includes PROMs specific to their condition, such as the Western Ontario Shoulder Instability (WOSI) index.²⁰ For patients with knee instability, similar considerations apply; specific measures such as the Lysholm score and the Tenger Activity Scale capture the impact of injury in physically demanding activities.²¹ When selecting disease-specific PROMs, providers should consult articles like those by Davidson and Keating²² and Bent and colleagues,²³ who present provider-friendly tools that can be used to examine the effectiveness of a PROM, and provide additional background information on selecting disease-specific PROMs. For hip and knee arthroplasty subspecialties, the International Society of Arthroplasty Registries (ISAR) created a working group that determines best practices for PROM collection and identifies PROMs most commonly reported in arthroplasty.²⁴

Questionnaire Length Considerations

When PROMs are used in a practice, a balance must be struck between gathering enough information to determine functionality and limiting the patient burden of questionnaire length. A decision to use several PROMs all at once, at a single data collection point, can lengthen the questionnaire significantly. One study found that, with use of longer questionnaires, patients may lose interest, resulting in decreased reliability and compliance.²⁵ For example, providers who use the long (42-item) Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire to assess knee function are often limited in what other PROMs they may administer at the same time. Efforts to shorten this questionnaire while still capturing necessary information led to the development of the 7-item KOOS Jr, which was validated for use in knee arthroplasty and had its 7 items drawn from the original 42.²⁶ Similarly, the 40-item Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire was shortened to the 6-item HOOS Jr, which was validated for use in hip arthroplasty,²⁷ and the generic SF-36 was shortened to the SF-12.¹¹ Providers trying to build an outcomes database while minimizing patient burden should consider using the shorter versions of these questionnaires but should also consider their validity, as KOOS Jr and HOOS Jr have been validated for use only in knee and hip arthroplasty and not in other knee and hip conditions.

PROM Data Collection Considerations

Comprehensive collection of longitudinal PROM data poses many challenges for providers and patients. For providers, the greatest challenges are infrastructure, technology, and the personnel needed to administer and store paper or electronic surveys. For patients, the most common survey completion barriers are questionnaire length, confusing or irrelevant content, and, in the case of some older adults, inability to complete surveys electronically.²⁵

Identifying a nonresponsive or noncompliant patient population is an important issue in collecting PROM data for research or other purposes. A study of factors associated with higher nonresponse rates in elective surgery patients (N = 135,474) found that noncompliance was higher for males, patients under age 55 years, nonwhites, patients in the lowest socioeconomic quintile, patients living alone, patients needing assistance in completing questionnaires, and patients who previously underwent surgery for their condition.²⁸ In a systematic review of methods that increased the response rates of postal and electronic surveys, Edwards and colleagues²⁹ found significantly higher odds of response for patients who were prenotified of the survey, given shorter questionnaires, or given a deadline for survey completion. Of note, response rates were lower when the word survey was used in the subject line of an email. 

PROM distribution has evolved with the rise of technological advances that allow for electronic survey distribution and data capture. Several studies have found that electronically administered PROMs have high response rates.^3,30,31 In a study of patients who underwent total hip arthroplasty, Rolfson and colleagues³² found that response rates were significantly higher for those who were surveyed on paper than for those surveyed over the internet. A randomized controlled study found that, compared with paper surveys, digital tablet surveys effectively and reliably collected PROM data; in addition, digital tablets provided instant data storage, and improved survey completion by requiring that all questions be answered before the survey could be submitted.33 However, age, race/ethnicity, and income disparities in technology use must be considered when administering internet-based follow-up surveys and analyzing data collected with web-based methods.³⁴ A study of total joint arthroplasty candidates found that several groups were less likely to complete electronic PROM questionnaires: patients over age 75 years, Hispanic or black patients, patients with Medicare or Medicaid, patients who previously underwent orthopedic surgery, patients undergoing revision total joint arthroplasty, patients with other comorbidities, and patients whose primary language was not English.³⁵ Providers interested in implementing PROMs must consider their patient population when selecting a method for survey distribution and follow-up. A study found that a majority of PROMs were written at a level many patients may not have understood, because of their literacy level or age; this lack of understanding created a barrier to compliance in many patient populations.³⁶

PROM Limitations and PROMIS Use

Use of PROMs has its limitations. The large variety of PROMs available for use in orthopedic surgery has led to several standardization initiatives. The National Institutes of Health funded the development of PROMIS, a person-centered measures database that evaluates and monitors the physical, social, and emotional health of adults and children.³⁷ The goal of PROMIS is to develop a standardized method of selecting PROMs, so that all medical disciplines and subspecialties can choose an applicable set of questions from the PROMIS question bank and use it in practice. Orthopedic surgery can use questions pertaining to physical functioning of the lower and upper extremities as well as quality of life and mental health. PROMIS physical function questions have been validated for use in several areas of orthopedic surgery.^38-40 A disadvantage of PROMIS is the overgenerality of its questions, which may not be as effective in capturing the implications of specific diagnoses. For example, it is difficult to use generalized questions to determine the implications of a diagnosis such as shoulder instability, which may affect only higher functioning activities or sports. More research on best PROM selection practices is needed in order to either standardize PROMs or move toward use of a single database such as PROMIS.

Future Directions in PROM Applications

PROMs are being used for research and patient engagement, but there are many other applications on the horizon. As already mentioned, predictive modeling is of particular interest. The existence of vast collaborative PROM databases that capture a diverse patient population introduces the possibility of creating models capable of predicting a patient outcome and enhancing shared decision-making.³ Predicting good or excellent patient outcomes for specific patient populations may allow elimination of certain postoperative visits, thereby creating more cost-effective care and reducing the burden of unnecessary clinic visits for both patients and physicians.

As with other healthcare areas, PROM data collection technology is rapidly advancing. Not only has electronic technology almost entirely replaced paper-and-pencil collection methods, but a new method of outcome data collection has been developed: computerized adaptive testing (CAT). CAT uses item-response theory to minimize the number of questions patients must answer in order for validated and reliable outcome scores to be calculated. According to multiple studies, CAT used across several questionnaires has reliably assessed PROMs while minimizing floor and ceiling effects, eliminating irrelevant questions, and shortening survey completion time.^41-43

Besides becoming more patient-friendly and accessible across multiple interfaces (mobile devices and computers), PROMs are also beginning to be integrated into the electronic medical record, allowing easier access to information during chart reviews. Use of statistical and predictive modeling, as described by Chang,³ could give PROMs a role in clinical decision-making. Informing patients of their expected outcome and recovery trajectory—based on demographics, comorbidities, preoperative functional status, and other factors—could influence their decision to undergo surgical intervention. As Halawi and colleagues⁴⁴ pointed out, it is important to discuss patient expectations before surgery, as unrealistic ones can negatively affect outcomes and lead to dissatisfaction. With clinicians having ready access to statistics and models in patient charts, we may see a transformation in clinical practices and surgical decision-making.

Conclusion

PROMs offer many ways to improve research and clinical care in orthopedic surgery. However, implementing PROMs in practice is not without challenges. Interested orthopedic surgeons should select the PROMs that are most appropriate—reliable, validated, and responsive to their patient population. Electronic distribution of PROM questionnaires is effective and allows data to be stored on entry, but orthopedic surgeons must consider their patient population to ensure accurate data capture and compliance in longitudinal surveys. Proper implementation of PROMs in a practice can allow clinicians to formulate expectations for postoperative recovery and set reasonable postoperative goals while engaging patients in improving quality of care.

Take-Home Points

• The SCR is a viable treatment option for massive, irreparable RCTs.
• Arm position and exact measurement between anchors will help ensure proper graft tensioning.
• Anterior and posterior tension and margin convergence are critical to stabilizing the graft.
• Acromial-humeral distance, ASES, and VAS scores are improved and maintained over long-term follow-up.
• The dermal allograft should be 3.0 mm or thicker.

Conventional treatments for irreparable massive rotator cuff tears (RCTs) have ranged from nonoperative care to débridement and biceps tenotomy,^1,2 partial cuff repair,^3,4 bridging patch grafts,⁵ tendon transfers,^6,7 and reverse total shoulder arthroplasty (RTSA).^8,9 Superior capsular reconstruction (SCR), originally described by Mihata and colleagues,¹⁰ has been developed as an alternative to these interventions. Dr. Hirahara modified the technique to use dermal allograft instead of fascia lata autograft.^10,11

Biomechanical analysis has confirmed the integral role of the superior capsule in shoulder function.^10,12-14 In the presence of a massive RCT, the humeral head migrates superiorly, causing significant pain and functional deficits, such as pseudoparalysis. It is theorized that reestablishing this important stabilizer—centering the humeral head in the glenoid and allowing the larger muscles to move the arm about a proper fulcrum—improves function and decreases pain.

Using ultrasonography (US), radiography, magnetic resonance imaging (MRI), clinical outcome scores, and a visual analog scale (VAS) for pain, we prospectively evaluated minimum 2-year clinical outcomes of performing SCR with dermal allograft for irreparable RCTs.

Methods

Except where noted otherwise, all products mentioned in this section were made by Arthrex.

Surgical Technique

The surgical technique used here was described by Hirahara and Adams.¹¹ ArthroFlex dermal allograft was attached to the greater tuberosity and the glenoid, creating a superior restraint that replaced the anatomical superior capsule (Figures 1A, 1B). Some cases included biceps tenotomy, subscapularis repair, or infraspinatus repair.

Medial fixation was obtained with a PASTA (partial articular supraspinatus tendon avulsion) bridge-type construct¹⁵ that consisted of two 3.0-mm BioComposite SutureTak anchors (placed medially on the glenoid rim, medial to the labrum) and a 3.5-mm BioComposite Vented SwiveLock. In some cases, a significant amount of tissue was present medially, and the third anchor was not used; instead, a double surgeon knot was used to fixate the double pulley medially.

Posterior margin convergence (PMC) was performed in all cases. Anterior margin convergence (AMC) was performed in only 3 cases.

Clinical Evaluation

All patients who underwent SCR were followed prospectively, and all signed an informed consent form. Between 2014 and the time of this study, 9 patients had surgery with a minimum 2-year follow-up. Before surgery, all patients received a diagnosis of full-thickness RCT with decreased acromial-humeral distance (AHD). One patient had RTSA 18 months after surgery, did not reach the 2-year follow-up, and was excluded from the data analysis. Patients were clinically evaluated on the 100-point American Shoulder and Elbow Surgeons (ASES) shoulder index and on a 10-point VAS for pain—before surgery, monthly for the first 6 months after surgery, then every 6 months until 2 years after surgery, and yearly thereafter. These patients were compared with Dr. Hirahara’s historical control patients, who had undergone repair of massive RCTs. Mean graft size was calculated and reported. Cases were separated and analyzed on the basis of whether AMC was performed. Student t tests were used to determine statistical differences between study patients’ preoperative and postoperative scores, between study and historical control patients, and between patients who had AMC performed and those who did not (P < .05).

Imaging

For all SCR patients, preoperative and postoperative radiographs were obtained in 2 planes: anterior-posterior with arm in neutral rotation, and scapular Y. On anteroposterior radiographs, AHD was measured from the most proximal aspect of the humeral head in a vertical line to the most inferior portion of the acromion (Figures 2A, 2B).

Results

The Table provides an overview of the study results. Eight patients (6 men, 2 women) met the final inclusion criteria for postoperative ASES and VAS data analysis.

AHD was measured on a standard anteroposterior radiograph in neutral rotation. The Hamada grading scale16 was used to classify the massive RCTs before and after surgery. Before surgery, 4 were grade 4A, 1 grade 3, 2 grade 2, and 1 grade 1; immediately after surgery, all were grade 1 (AHD, ≥6 mm). Two years after surgery, 1 patient had an AHD of 4.6 mm after a failure caused by a fall. Mean (SD) preoperative AHD was 4.50 (2.25) mm (range, 1.7-7.9 mm). Radiographs obtained immediately (mean, 1.22 months; range, 1 day-2.73 months) after surgery showed AHD was significantly (P < .0008) increased (mean, 8.48 mm; SD, 1.25 mm; range, 6.0-10.0 mm) (Figure 5).

Mean graft size was 2.9 mm medial × 3.6 mm lateral × 5.4 mm anterior × 5.4 mm posterior. Three patients had AMC performed. There was a significant (P < .05) difference in ASES scores between patients who had AMC performed (93) and those who did not (77).

Ultrasonography

Two weeks to 2 months after surgery, all patients had an intact capsular graft and no pulsatile vessels on US. Between 4 months and 10 months, US showed the construct intact laterally in all cases, a pulsatile vessel in the graft at the tuberosity (evidence of blood flow) in 4 of 5 cases, and a pulsatile vessel hypertrophied in 2 cases (Figures 6A, 6B).

Magnetic Resonance Imaging

Before surgery, 4 patients had Goutallier¹⁷ stage 4 rotator cuff muscle degeneration, 2 had stage 3 degeneration, and 2 had stage 2 degeneration. Throughout the follow-up period, US was as effective as MRI in determining graft integrity, graft thickness, and greater tuberosity fixation. Therefore, the SCRs were assessed primarily with US. MRI was ordered only if a failure was suspected or if the patient had some form of trauma. A total of 7 MRIs were ordered for 5 of the 8 patients in the study. The graft was intact in 4 of the 5 (Figures 7A-7C) and ruptured in the fifth.

Discussion

Mihata and colleagues¹⁰ published 2-year data for their reconstructive procedure with fascia lata autograft. In a modification of their procedure, Dr. Hirahara used dermal allograft to recreate the superior capsule.¹¹ The results of the present 2-year study mirror the clinical outcomes reported by Mihata and colleagues¹⁰ and confirm that SCR improves functional outcomes and increases AHD regardless of graft type used.

The outcomes of the SCR patients in our study were significantly better than the outcomes of the historical control patients, who underwent repair of massive RCTs. Although there was no significant difference in the 2 groups’ ASES scores, the control patients had significantly higher postoperative VAS pain scores. We think that, as more patients undergo SCR and the population sample increases, we will see a significant difference in ASES scores as well (our SCR patients already showed a trend toward improved ASES scores).

Compared with RTSA, SCR has fewer risks and fewer complications and does not limit further surgical options.^8,9,18 The 9 patients who had surgery with a minimum 2-year follow-up in our study had 4 complications. Six months after surgery, 1 patient fell and tore the infraspinatus and subscapularis muscles. Outcomes continued to improve, and no issues were reported, despite a decrease in AHD, from 8 mm immediately after surgery to 4.6 mm 2 years after surgery.

Two patients were in motor vehicle accidents. In 1 case, the accident occurred about 2 months after surgery. This patient also sustained a possible injury in a fall after receiving general anesthesia for a dental procedure. After having done very well the preceding months, the patient now reported increasing pain and dysfunction. MRI showed loss of glenoid fixation. Improved ASES and VAS pain scores were maintained throughout the follow-up period. AHD was increased at 13 months and mildly decreased at 2 years. Glenoid fixation was obtained with 2 anchors and a double surgeon knot. When possible, however, it is best to add an anchor and double-row fixation, as 3 anchors and a double-row construct are biomechanically stronger.^19-24

The other motor vehicle accident occurred about 23 months after surgery. Two months later, a graft rupture was found on US and MRI, but the patient was maintaining full range of motion, AHD, and improved strength. The 1.5-mm graft in this patient was thinner than the 3.5-mm grafts in the rest of the study group. This was the only patient who developed a graft rupture rather than loss of fixation.

If only patients with graft thickness >3.0 mm are included in the data analysis, mean ASES score rises to 89.76, and mean VAS pain score drops to 0. Therefore, we argue against using a graft thinner than 3.5 mm. Our excellent study results indicate that larger grafts are unnecessary. Mihata and colleagues¹⁰ used fascia lata grafts of 6 mm to 8 mm. Ultimate load to failure is significantly higher for dermal allograft than for fascia lata graft.²⁵ In SCR, the stronger dermal allograft withstands applied forces and repeated deformations and has excellent clinical outcomes.

Only 1 patient had a failure that required RTSA. VAS pain scores were lower and ASES scores were improved the first year after surgery, but then function deteriorated. The patient said there was no specific precipitating incident. Computed tomography arthrogram, ordered to assess the construct, showed anterior and superior subluxation of the humeral head, even with an intact subscapularis tendon—an indication of underlying instability, which most likely caused the failure. Eighteen months after surgery, the patient was able to undergo RTSA. On further evaluation of this patient’s procedure, it was determined that the graft needed better fixation anteriorly.

Mihata and colleagues^10,12,14 indicated that AMC was unnecessary, and our procedure did not require it. However, data in our prospective evaluation began showing improved outcomes with AMC. As dermal allograft is more elastic than fascia lata autograft,²⁵ we concluded that graft tensioning is key to the success of this procedure. Graft tension depends on many factors, including exact measurement of the distances between the anchors to punch holes in the graft, arm position to set the relationship between the anchor distances, and AMC and PMC. We recommend placing the arm in neutral rotation, neutral flexion, and abduction with the patient at rest, based on the size of the patient’s latissimus dorsi. Too much abduction causes overtensioning, and excess rotation or flexion-extension changes the distance between the glenoid and the greater tuberosity asymmetrically, from anterior to posterior. With the arm in neutral position, distances between anchors are accurately measured, and these measurements are used to determine graft size.

Graft tension is also needed to control the amount of elasticity allowed by the graft and thereby maintain stability, as shown by the Poisson ratio, the ratio of transverse contraction to longitudinal extension on a material in the presence of a stretching force. As applied to SCR, it is the ratio of mediolateral elasticity to anteroposterior deformation or constraint. If the graft is appropriately secured in the anteroposterior direction by way of ACM and PMC, elongation in the medial-lateral direction will be limited—reducing the elasticity of the graft, improving overall stability, and ultimately producing better clinical outcomes. This issue was discussed by Burkhart and colleagues²⁶ with respect to the “rotator cable complex,” which now might be best described as the “rotator-capsule cable complex.” In our study, this phenomenon was evident in the finding that patients who had AMC performed did significantly better than patients who did not have AMC performed. The ability of dermal allograft to deform in these dimensions without failure while allowing excellent range of motion makes dermal allograft an exceptional choice for grafting during SCR. Mihata25 also found dermal allograft had a clear advantage in providing better range of motion, whereas fascia lata autograft resulted in a stiffer construct. 

Dermal allograft can also incorporate into the body and transform into host tissue. The literature has described musculoskeletal US as an effective diagnostic and interventional tool.^27-31 We used it to evaluate graft size, patency, and viability. As can be seen on US, the native rotator cuff does not have any pulsatile vessels and is fed by capillary flow. Dermal allograft has native vasculature built into the tissue. After 4 months to 8 months, presence of pulsatile vessels within the graft at the greater tuberosity indicates clear revascularization and incorporation of the tissue (Figure 6B). Disappearance of pulsatile vessels on US after 1 year indicates transformation to a stabilizing structure analogous to capsule or ligament with capillary flow. US also showed graft hypertrophy after 2 years, supporting a finding of integration and growth.

Conclusion

In the past, patients with irreparable massive RCTs had few good surgical management options, RTSA being the most definitive. SCR is technically challenging and requires use of specific implantation methods but can provide patients with outstanding relief. Our clinical data showed that technically well executed SCR effectively restores the superior restraints in the glenohumeral joint and thereby increases function and decreases pain in patients with irreparable massive RCTs, even after 2 years.

Take-Home Points

• The SCR is a viable treatment option for massive, irreparable RCTs.
• Arm position and exact measurement between anchors will help ensure proper graft tensioning.
• Anterior and posterior tension and margin convergence are critical to stabilizing the graft.
• Acromial-humeral distance, ASES, and VAS scores are improved and maintained over long-term follow-up.
• The dermal allograft should be 3.0 mm or thicker.

Conventional treatments for irreparable massive rotator cuff tears (RCTs) have ranged from nonoperative care to débridement and biceps tenotomy,^1,2 partial cuff repair,^3,4 bridging patch grafts,⁵ tendon transfers,^6,7 and reverse total shoulder arthroplasty (RTSA).^8,9 Superior capsular reconstruction (SCR), originally described by Mihata and colleagues,¹⁰ has been developed as an alternative to these interventions. Dr. Hirahara modified the technique to use dermal allograft instead of fascia lata autograft.^10,11

Biomechanical analysis has confirmed the integral role of the superior capsule in shoulder function.^10,12-14 In the presence of a massive RCT, the humeral head migrates superiorly, causing significant pain and functional deficits, such as pseudoparalysis. It is theorized that reestablishing this important stabilizer—centering the humeral head in the glenoid and allowing the larger muscles to move the arm about a proper fulcrum—improves function and decreases pain.

Using ultrasonography (US), radiography, magnetic resonance imaging (MRI), clinical outcome scores, and a visual analog scale (VAS) for pain, we prospectively evaluated minimum 2-year clinical outcomes of performing SCR with dermal allograft for irreparable RCTs.

Methods

Except where noted otherwise, all products mentioned in this section were made by Arthrex.

Surgical Technique

The surgical technique used here was described by Hirahara and Adams.¹¹ ArthroFlex dermal allograft was attached to the greater tuberosity and the glenoid, creating a superior restraint that replaced the anatomical superior capsule (Figures 1A, 1B). Some cases included biceps tenotomy, subscapularis repair, or infraspinatus repair.

Medial fixation was obtained with a PASTA (partial articular supraspinatus tendon avulsion) bridge-type construct¹⁵ that consisted of two 3.0-mm BioComposite SutureTak anchors (placed medially on the glenoid rim, medial to the labrum) and a 3.5-mm BioComposite Vented SwiveLock. In some cases, a significant amount of tissue was present medially, and the third anchor was not used; instead, a double surgeon knot was used to fixate the double pulley medially.

Posterior margin convergence (PMC) was performed in all cases. Anterior margin convergence (AMC) was performed in only 3 cases.

Clinical Evaluation

All patients who underwent SCR were followed prospectively, and all signed an informed consent form. Between 2014 and the time of this study, 9 patients had surgery with a minimum 2-year follow-up. Before surgery, all patients received a diagnosis of full-thickness RCT with decreased acromial-humeral distance (AHD). One patient had RTSA 18 months after surgery, did not reach the 2-year follow-up, and was excluded from the data analysis. Patients were clinically evaluated on the 100-point American Shoulder and Elbow Surgeons (ASES) shoulder index and on a 10-point VAS for pain—before surgery, monthly for the first 6 months after surgery, then every 6 months until 2 years after surgery, and yearly thereafter. These patients were compared with Dr. Hirahara’s historical control patients, who had undergone repair of massive RCTs. Mean graft size was calculated and reported. Cases were separated and analyzed on the basis of whether AMC was performed. Student t tests were used to determine statistical differences between study patients’ preoperative and postoperative scores, between study and historical control patients, and between patients who had AMC performed and those who did not (P < .05).

Imaging

For all SCR patients, preoperative and postoperative radiographs were obtained in 2 planes: anterior-posterior with arm in neutral rotation, and scapular Y. On anteroposterior radiographs, AHD was measured from the most proximal aspect of the humeral head in a vertical line to the most inferior portion of the acromion (Figures 2A, 2B).

Results

The Table provides an overview of the study results. Eight patients (6 men, 2 women) met the final inclusion criteria for postoperative ASES and VAS data analysis.

AHD was measured on a standard anteroposterior radiograph in neutral rotation. The Hamada grading scale16 was used to classify the massive RCTs before and after surgery. Before surgery, 4 were grade 4A, 1 grade 3, 2 grade 2, and 1 grade 1; immediately after surgery, all were grade 1 (AHD, ≥6 mm). Two years after surgery, 1 patient had an AHD of 4.6 mm after a failure caused by a fall. Mean (SD) preoperative AHD was 4.50 (2.25) mm (range, 1.7-7.9 mm). Radiographs obtained immediately (mean, 1.22 months; range, 1 day-2.73 months) after surgery showed AHD was significantly (P < .0008) increased (mean, 8.48 mm; SD, 1.25 mm; range, 6.0-10.0 mm) (Figure 5).

Mean graft size was 2.9 mm medial × 3.6 mm lateral × 5.4 mm anterior × 5.4 mm posterior. Three patients had AMC performed. There was a significant (P < .05) difference in ASES scores between patients who had AMC performed (93) and those who did not (77).

Ultrasonography

Two weeks to 2 months after surgery, all patients had an intact capsular graft and no pulsatile vessels on US. Between 4 months and 10 months, US showed the construct intact laterally in all cases, a pulsatile vessel in the graft at the tuberosity (evidence of blood flow) in 4 of 5 cases, and a pulsatile vessel hypertrophied in 2 cases (Figures 6A, 6B).

Magnetic Resonance Imaging

Before surgery, 4 patients had Goutallier¹⁷ stage 4 rotator cuff muscle degeneration, 2 had stage 3 degeneration, and 2 had stage 2 degeneration. Throughout the follow-up period, US was as effective as MRI in determining graft integrity, graft thickness, and greater tuberosity fixation. Therefore, the SCRs were assessed primarily with US. MRI was ordered only if a failure was suspected or if the patient had some form of trauma. A total of 7 MRIs were ordered for 5 of the 8 patients in the study. The graft was intact in 4 of the 5 (Figures 7A-7C) and ruptured in the fifth.

Discussion

Mihata and colleagues¹⁰ published 2-year data for their reconstructive procedure with fascia lata autograft. In a modification of their procedure, Dr. Hirahara used dermal allograft to recreate the superior capsule.¹¹ The results of the present 2-year study mirror the clinical outcomes reported by Mihata and colleagues¹⁰ and confirm that SCR improves functional outcomes and increases AHD regardless of graft type used.

The outcomes of the SCR patients in our study were significantly better than the outcomes of the historical control patients, who underwent repair of massive RCTs. Although there was no significant difference in the 2 groups’ ASES scores, the control patients had significantly higher postoperative VAS pain scores. We think that, as more patients undergo SCR and the population sample increases, we will see a significant difference in ASES scores as well (our SCR patients already showed a trend toward improved ASES scores).

Compared with RTSA, SCR has fewer risks and fewer complications and does not limit further surgical options.^8,9,18 The 9 patients who had surgery with a minimum 2-year follow-up in our study had 4 complications. Six months after surgery, 1 patient fell and tore the infraspinatus and subscapularis muscles. Outcomes continued to improve, and no issues were reported, despite a decrease in AHD, from 8 mm immediately after surgery to 4.6 mm 2 years after surgery.

Two patients were in motor vehicle accidents. In 1 case, the accident occurred about 2 months after surgery. This patient also sustained a possible injury in a fall after receiving general anesthesia for a dental procedure. After having done very well the preceding months, the patient now reported increasing pain and dysfunction. MRI showed loss of glenoid fixation. Improved ASES and VAS pain scores were maintained throughout the follow-up period. AHD was increased at 13 months and mildly decreased at 2 years. Glenoid fixation was obtained with 2 anchors and a double surgeon knot. When possible, however, it is best to add an anchor and double-row fixation, as 3 anchors and a double-row construct are biomechanically stronger.^19-24

The other motor vehicle accident occurred about 23 months after surgery. Two months later, a graft rupture was found on US and MRI, but the patient was maintaining full range of motion, AHD, and improved strength. The 1.5-mm graft in this patient was thinner than the 3.5-mm grafts in the rest of the study group. This was the only patient who developed a graft rupture rather than loss of fixation.

If only patients with graft thickness >3.0 mm are included in the data analysis, mean ASES score rises to 89.76, and mean VAS pain score drops to 0. Therefore, we argue against using a graft thinner than 3.5 mm. Our excellent study results indicate that larger grafts are unnecessary. Mihata and colleagues¹⁰ used fascia lata grafts of 6 mm to 8 mm. Ultimate load to failure is significantly higher for dermal allograft than for fascia lata graft.²⁵ In SCR, the stronger dermal allograft withstands applied forces and repeated deformations and has excellent clinical outcomes.

Only 1 patient had a failure that required RTSA. VAS pain scores were lower and ASES scores were improved the first year after surgery, but then function deteriorated. The patient said there was no specific precipitating incident. Computed tomography arthrogram, ordered to assess the construct, showed anterior and superior subluxation of the humeral head, even with an intact subscapularis tendon—an indication of underlying instability, which most likely caused the failure. Eighteen months after surgery, the patient was able to undergo RTSA. On further evaluation of this patient’s procedure, it was determined that the graft needed better fixation anteriorly.

Mihata and colleagues^10,12,14 indicated that AMC was unnecessary, and our procedure did not require it. However, data in our prospective evaluation began showing improved outcomes with AMC. As dermal allograft is more elastic than fascia lata autograft,²⁵ we concluded that graft tensioning is key to the success of this procedure. Graft tension depends on many factors, including exact measurement of the distances between the anchors to punch holes in the graft, arm position to set the relationship between the anchor distances, and AMC and PMC. We recommend placing the arm in neutral rotation, neutral flexion, and abduction with the patient at rest, based on the size of the patient’s latissimus dorsi. Too much abduction causes overtensioning, and excess rotation or flexion-extension changes the distance between the glenoid and the greater tuberosity asymmetrically, from anterior to posterior. With the arm in neutral position, distances between anchors are accurately measured, and these measurements are used to determine graft size.

Graft tension is also needed to control the amount of elasticity allowed by the graft and thereby maintain stability, as shown by the Poisson ratio, the ratio of transverse contraction to longitudinal extension on a material in the presence of a stretching force. As applied to SCR, it is the ratio of mediolateral elasticity to anteroposterior deformation or constraint. If the graft is appropriately secured in the anteroposterior direction by way of ACM and PMC, elongation in the medial-lateral direction will be limited—reducing the elasticity of the graft, improving overall stability, and ultimately producing better clinical outcomes. This issue was discussed by Burkhart and colleagues²⁶ with respect to the “rotator cable complex,” which now might be best described as the “rotator-capsule cable complex.” In our study, this phenomenon was evident in the finding that patients who had AMC performed did significantly better than patients who did not have AMC performed. The ability of dermal allograft to deform in these dimensions without failure while allowing excellent range of motion makes dermal allograft an exceptional choice for grafting during SCR. Mihata25 also found dermal allograft had a clear advantage in providing better range of motion, whereas fascia lata autograft resulted in a stiffer construct. 

Dermal allograft can also incorporate into the body and transform into host tissue. The literature has described musculoskeletal US as an effective diagnostic and interventional tool.^27-31 We used it to evaluate graft size, patency, and viability. As can be seen on US, the native rotator cuff does not have any pulsatile vessels and is fed by capillary flow. Dermal allograft has native vasculature built into the tissue. After 4 months to 8 months, presence of pulsatile vessels within the graft at the greater tuberosity indicates clear revascularization and incorporation of the tissue (Figure 6B). Disappearance of pulsatile vessels on US after 1 year indicates transformation to a stabilizing structure analogous to capsule or ligament with capillary flow. US also showed graft hypertrophy after 2 years, supporting a finding of integration and growth.

Conclusion

In the past, patients with irreparable massive RCTs had few good surgical management options, RTSA being the most definitive. SCR is technically challenging and requires use of specific implantation methods but can provide patients with outstanding relief. Our clinical data showed that technically well executed SCR effectively restores the superior restraints in the glenohumeral joint and thereby increases function and decreases pain in patients with irreparable massive RCTs, even after 2 years.

Take-Home Points

• The SCR is a viable treatment option for massive, irreparable RCTs.
• Arm position and exact measurement between anchors will help ensure proper graft tensioning.
• Anterior and posterior tension and margin convergence are critical to stabilizing the graft.
• Acromial-humeral distance, ASES, and VAS scores are improved and maintained over long-term follow-up.
• The dermal allograft should be 3.0 mm or thicker.

Conventional treatments for irreparable massive rotator cuff tears (RCTs) have ranged from nonoperative care to débridement and biceps tenotomy,^1,2 partial cuff repair,^3,4 bridging patch grafts,⁵ tendon transfers,^6,7 and reverse total shoulder arthroplasty (RTSA).^8,9 Superior capsular reconstruction (SCR), originally described by Mihata and colleagues,¹⁰ has been developed as an alternative to these interventions. Dr. Hirahara modified the technique to use dermal allograft instead of fascia lata autograft.^10,11

Biomechanical analysis has confirmed the integral role of the superior capsule in shoulder function.^10,12-14 In the presence of a massive RCT, the humeral head migrates superiorly, causing significant pain and functional deficits, such as pseudoparalysis. It is theorized that reestablishing this important stabilizer—centering the humeral head in the glenoid and allowing the larger muscles to move the arm about a proper fulcrum—improves function and decreases pain.

Using ultrasonography (US), radiography, magnetic resonance imaging (MRI), clinical outcome scores, and a visual analog scale (VAS) for pain, we prospectively evaluated minimum 2-year clinical outcomes of performing SCR with dermal allograft for irreparable RCTs.

Methods

Except where noted otherwise, all products mentioned in this section were made by Arthrex.

Surgical Technique

The surgical technique used here was described by Hirahara and Adams.¹¹ ArthroFlex dermal allograft was attached to the greater tuberosity and the glenoid, creating a superior restraint that replaced the anatomical superior capsule (Figures 1A, 1B). Some cases included biceps tenotomy, subscapularis repair, or infraspinatus repair.

Medial fixation was obtained with a PASTA (partial articular supraspinatus tendon avulsion) bridge-type construct¹⁵ that consisted of two 3.0-mm BioComposite SutureTak anchors (placed medially on the glenoid rim, medial to the labrum) and a 3.5-mm BioComposite Vented SwiveLock. In some cases, a significant amount of tissue was present medially, and the third anchor was not used; instead, a double surgeon knot was used to fixate the double pulley medially.

Posterior margin convergence (PMC) was performed in all cases. Anterior margin convergence (AMC) was performed in only 3 cases.

Clinical Evaluation

All patients who underwent SCR were followed prospectively, and all signed an informed consent form. Between 2014 and the time of this study, 9 patients had surgery with a minimum 2-year follow-up. Before surgery, all patients received a diagnosis of full-thickness RCT with decreased acromial-humeral distance (AHD). One patient had RTSA 18 months after surgery, did not reach the 2-year follow-up, and was excluded from the data analysis. Patients were clinically evaluated on the 100-point American Shoulder and Elbow Surgeons (ASES) shoulder index and on a 10-point VAS for pain—before surgery, monthly for the first 6 months after surgery, then every 6 months until 2 years after surgery, and yearly thereafter. These patients were compared with Dr. Hirahara’s historical control patients, who had undergone repair of massive RCTs. Mean graft size was calculated and reported. Cases were separated and analyzed on the basis of whether AMC was performed. Student t tests were used to determine statistical differences between study patients’ preoperative and postoperative scores, between study and historical control patients, and between patients who had AMC performed and those who did not (P < .05).

Imaging

For all SCR patients, preoperative and postoperative radiographs were obtained in 2 planes: anterior-posterior with arm in neutral rotation, and scapular Y. On anteroposterior radiographs, AHD was measured from the most proximal aspect of the humeral head in a vertical line to the most inferior portion of the acromion (Figures 2A, 2B).

Results

The Table provides an overview of the study results. Eight patients (6 men, 2 women) met the final inclusion criteria for postoperative ASES and VAS data analysis.

AHD was measured on a standard anteroposterior radiograph in neutral rotation. The Hamada grading scale16 was used to classify the massive RCTs before and after surgery. Before surgery, 4 were grade 4A, 1 grade 3, 2 grade 2, and 1 grade 1; immediately after surgery, all were grade 1 (AHD, ≥6 mm). Two years after surgery, 1 patient had an AHD of 4.6 mm after a failure caused by a fall. Mean (SD) preoperative AHD was 4.50 (2.25) mm (range, 1.7-7.9 mm). Radiographs obtained immediately (mean, 1.22 months; range, 1 day-2.73 months) after surgery showed AHD was significantly (P < .0008) increased (mean, 8.48 mm; SD, 1.25 mm; range, 6.0-10.0 mm) (Figure 5).

Mean graft size was 2.9 mm medial × 3.6 mm lateral × 5.4 mm anterior × 5.4 mm posterior. Three patients had AMC performed. There was a significant (P < .05) difference in ASES scores between patients who had AMC performed (93) and those who did not (77).

Ultrasonography

Two weeks to 2 months after surgery, all patients had an intact capsular graft and no pulsatile vessels on US. Between 4 months and 10 months, US showed the construct intact laterally in all cases, a pulsatile vessel in the graft at the tuberosity (evidence of blood flow) in 4 of 5 cases, and a pulsatile vessel hypertrophied in 2 cases (Figures 6A, 6B).

Magnetic Resonance Imaging

Before surgery, 4 patients had Goutallier¹⁷ stage 4 rotator cuff muscle degeneration, 2 had stage 3 degeneration, and 2 had stage 2 degeneration. Throughout the follow-up period, US was as effective as MRI in determining graft integrity, graft thickness, and greater tuberosity fixation. Therefore, the SCRs were assessed primarily with US. MRI was ordered only if a failure was suspected or if the patient had some form of trauma. A total of 7 MRIs were ordered for 5 of the 8 patients in the study. The graft was intact in 4 of the 5 (Figures 7A-7C) and ruptured in the fifth.

Discussion

Mihata and colleagues¹⁰ published 2-year data for their reconstructive procedure with fascia lata autograft. In a modification of their procedure, Dr. Hirahara used dermal allograft to recreate the superior capsule.¹¹ The results of the present 2-year study mirror the clinical outcomes reported by Mihata and colleagues¹⁰ and confirm that SCR improves functional outcomes and increases AHD regardless of graft type used.

The outcomes of the SCR patients in our study were significantly better than the outcomes of the historical control patients, who underwent repair of massive RCTs. Although there was no significant difference in the 2 groups’ ASES scores, the control patients had significantly higher postoperative VAS pain scores. We think that, as more patients undergo SCR and the population sample increases, we will see a significant difference in ASES scores as well (our SCR patients already showed a trend toward improved ASES scores).

Compared with RTSA, SCR has fewer risks and fewer complications and does not limit further surgical options.^8,9,18 The 9 patients who had surgery with a minimum 2-year follow-up in our study had 4 complications. Six months after surgery, 1 patient fell and tore the infraspinatus and subscapularis muscles. Outcomes continued to improve, and no issues were reported, despite a decrease in AHD, from 8 mm immediately after surgery to 4.6 mm 2 years after surgery.

Two patients were in motor vehicle accidents. In 1 case, the accident occurred about 2 months after surgery. This patient also sustained a possible injury in a fall after receiving general anesthesia for a dental procedure. After having done very well the preceding months, the patient now reported increasing pain and dysfunction. MRI showed loss of glenoid fixation. Improved ASES and VAS pain scores were maintained throughout the follow-up period. AHD was increased at 13 months and mildly decreased at 2 years. Glenoid fixation was obtained with 2 anchors and a double surgeon knot. When possible, however, it is best to add an anchor and double-row fixation, as 3 anchors and a double-row construct are biomechanically stronger.^19-24

The other motor vehicle accident occurred about 23 months after surgery. Two months later, a graft rupture was found on US and MRI, but the patient was maintaining full range of motion, AHD, and improved strength. The 1.5-mm graft in this patient was thinner than the 3.5-mm grafts in the rest of the study group. This was the only patient who developed a graft rupture rather than loss of fixation.

If only patients with graft thickness >3.0 mm are included in the data analysis, mean ASES score rises to 89.76, and mean VAS pain score drops to 0. Therefore, we argue against using a graft thinner than 3.5 mm. Our excellent study results indicate that larger grafts are unnecessary. Mihata and colleagues¹⁰ used fascia lata grafts of 6 mm to 8 mm. Ultimate load to failure is significantly higher for dermal allograft than for fascia lata graft.²⁵ In SCR, the stronger dermal allograft withstands applied forces and repeated deformations and has excellent clinical outcomes.

Only 1 patient had a failure that required RTSA. VAS pain scores were lower and ASES scores were improved the first year after surgery, but then function deteriorated. The patient said there was no specific precipitating incident. Computed tomography arthrogram, ordered to assess the construct, showed anterior and superior subluxation of the humeral head, even with an intact subscapularis tendon—an indication of underlying instability, which most likely caused the failure. Eighteen months after surgery, the patient was able to undergo RTSA. On further evaluation of this patient’s procedure, it was determined that the graft needed better fixation anteriorly.

Mihata and colleagues^10,12,14 indicated that AMC was unnecessary, and our procedure did not require it. However, data in our prospective evaluation began showing improved outcomes with AMC. As dermal allograft is more elastic than fascia lata autograft,²⁵ we concluded that graft tensioning is key to the success of this procedure. Graft tension depends on many factors, including exact measurement of the distances between the anchors to punch holes in the graft, arm position to set the relationship between the anchor distances, and AMC and PMC. We recommend placing the arm in neutral rotation, neutral flexion, and abduction with the patient at rest, based on the size of the patient’s latissimus dorsi. Too much abduction causes overtensioning, and excess rotation or flexion-extension changes the distance between the glenoid and the greater tuberosity asymmetrically, from anterior to posterior. With the arm in neutral position, distances between anchors are accurately measured, and these measurements are used to determine graft size.

Graft tension is also needed to control the amount of elasticity allowed by the graft and thereby maintain stability, as shown by the Poisson ratio, the ratio of transverse contraction to longitudinal extension on a material in the presence of a stretching force. As applied to SCR, it is the ratio of mediolateral elasticity to anteroposterior deformation or constraint. If the graft is appropriately secured in the anteroposterior direction by way of ACM and PMC, elongation in the medial-lateral direction will be limited—reducing the elasticity of the graft, improving overall stability, and ultimately producing better clinical outcomes. This issue was discussed by Burkhart and colleagues²⁶ with respect to the “rotator cable complex,” which now might be best described as the “rotator-capsule cable complex.” In our study, this phenomenon was evident in the finding that patients who had AMC performed did significantly better than patients who did not have AMC performed. The ability of dermal allograft to deform in these dimensions without failure while allowing excellent range of motion makes dermal allograft an exceptional choice for grafting during SCR. Mihata25 also found dermal allograft had a clear advantage in providing better range of motion, whereas fascia lata autograft resulted in a stiffer construct. 

Dermal allograft can also incorporate into the body and transform into host tissue. The literature has described musculoskeletal US as an effective diagnostic and interventional tool.^27-31 We used it to evaluate graft size, patency, and viability. As can be seen on US, the native rotator cuff does not have any pulsatile vessels and is fed by capillary flow. Dermal allograft has native vasculature built into the tissue. After 4 months to 8 months, presence of pulsatile vessels within the graft at the greater tuberosity indicates clear revascularization and incorporation of the tissue (Figure 6B). Disappearance of pulsatile vessels on US after 1 year indicates transformation to a stabilizing structure analogous to capsule or ligament with capillary flow. US also showed graft hypertrophy after 2 years, supporting a finding of integration and growth.

Conclusion

In the past, patients with irreparable massive RCTs had few good surgical management options, RTSA being the most definitive. SCR is technically challenging and requires use of specific implantation methods but can provide patients with outstanding relief. Our clinical data showed that technically well executed SCR effectively restores the superior restraints in the glenohumeral joint and thereby increases function and decreases pain in patients with irreparable massive RCTs, even after 2 years.