Rotator cuff tears are one of the leading causes of shoulder pain and disability, and they account for more than 250,000 ambulatory surgeries annually. As the population ages, the incidence of cases continues to rise, due primarily to degenerative shoulder conditions. Despite the billions of dollars spent annually on operative and non-operative treatments for rotator cuff tears, there is a lack of evidence on the comparative effectiveness of these two treatment strategies.
The urgent need for research in this area has been highlighted by the American Academy of Orthopaedic Surgeons (AAOS), the Agency for Healthcare Research and Quality (AHRQ) and other experts in the field. Now, a multisite study aims to address this question. The goals of the Arthroscopic Rotator Cuff repair (ARC) randomized controlled trial are in direct response to the concerns of patients and clinicians:
- To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic full-thickness rotator cuff tears at 12 months of follow-up
- To assess the effects of rotator cuff tear size and age on comparative outcomes measured by Shoulder Pain and Disability Index (SPADI) in operative versus non-operative treatments for atraumatic full-thickness rotator cuff tears
The five-year, $7.5 million grant is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is a multi-center randomized clinical trial that will enroll patients from 12 sites across the country. It will be headquartered at Vanderbilt University Medical Center. The goal is to recruit 700 patients with atraumatic full-thickness rotator cuff tears who are over fifty years of age and randomize them to either operative or non-operative treatments. Randomization to treatment is 1-1 and will be stratified by site and tear size.
The primary aim is to estimate the difference in 12-month SPADI change due to treatment, both marginally and adjusted for patient characteristics. Covariates of interest include baseline SPADI, gender, age, tear size, mental health and fatty infiltration.
A patient/stakeholder advisory board was established prior to the project’s proposal to obtain feedback on the primary research questions, outcome measures and conduct of study. Advisory board members include patients from diverse backgrounds, industry, insurance companies, surgeons, physical therapists, rehabilitation experts, imaging experts and researchers. A meeting is held approximately every other month at Vanderbilt, with members calling in who are not in Nashville.
“You miss an important piece of the puzzle if you don’t engage patients,” said Nitin Jain, M.D., M.S.P.H., of Vanderbilt Orthopaedic Institute, principal investigator in the study.
“Our outcomes measures are based on feedback from our patient partners. We present them with issues and they actively submit suggestions. They’re invaluable in making sure that surveys and other materials are easy to understand and that our research answers questions that are important to patients and stakeholders.”
Outcomes will include measures of shoulder pain and function using validated measures, with SPADI as the primary outcome. Secondary, patient-reported outcomes will be recorded with the American Shoulder and Elbow Surgeons (ASES) questionnaires. Investigators plan to set up a website to report findings.
“This is one of the most common reasons patients go to see their doctors,” said Jain. “It’s an important public health issue. This trial has the ability to inform clinical decision making and provide data to answer this much-asked question in musculoskeletal medicine. It would not be possible without the contributions of my entire team.”