Operative versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial
“It feels like a knife is stabbing my shoulder all the time,” a patient with a rotator cuff tear noted. Rotator cuff tears are the most common cause of shoulder pain and impact a patient’s quality of life. Patients with rotator cuff tears have difficulty with daily activities such as cooking, combing hair, reaching behind their back, and playing golf. The treatment of rotator cuff tear includes non-operative therapy and surgery. An estimated 272,148 rotator cuff surgeries were performed in the United States in 2006, and the rate of surgery as initial treatment is increasing over time. Treatment for rotator cuff tears costs the healthcare system billions of dollars, but there is little evidence available to determine whether surgery works any better than non-operative treatment. Due to this lack of evidence, patients are often left wondering: “What should I do if my shoulder hurts and I have a rotator cuff tear? Should I go for surgery or should I have physical therapy?” and “My MRI shows a large rotator cuff tear. Am I better off having surgery?”
The project team proposes a randomized clinical trial of surgery versus non-operative treatment. The researchers will use existing infrastructure from two large networks to recruit 500 patients who are ≥50 years of age and have atraumatic rotator cuff tears. Patients will be recruited from primary care and specialty practices. The two networks include: (a) Multicenter Orthopaedic Outcomes Network (MOON) consortium consisting of eight high-volume shoulder centers and over 30 surgeons; (b) PCORI-funded Mid-South Clinical Data Research Network (CDRN) at Vanderbilt that encompasses eight health systems in the mid-South and includes 45 hospitals, over 500 ambulatory sites, and engages over 3 million patients. A mix of academic and community-based practices will participate in the trial. The project team will compare pain and function in operative and non-operative groups at one-year follow-up. The researchers will also study how rotator cuff tear size (on MRI) and age impact pain and functional outcomes.
The proposed study is a direct result of meaningful patient and stakeholder engagement. The project team has an existing advisory board of six patient partners who come from diverse backgrounds. Other members of the stakeholder board include industry, insurance companies, surgeons, physical therapists, rehabilitation experts, imaging experts, and researchers. The project has support from influential professional agencies (Foundation for Physical Medicine and Rehabilitation, American Shoulder and Elbow Society, Arthroscopy Association of North America, and Foundation for Physical Therapy) involved in the care of patients with cuff tears. The researchers have gathered the patient/stakeholder advisory board on several occasions leading up to this proposal to obtain feedback on the primary research question, outcome measures, and conduct of study. Patients/stakeholders will continue to be involved in every aspect of the project during its conduct and assist with dissemination of findings.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.