Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears (ROW)

Vanderbilt University Medical Center

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Other: Observational Cohort

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02287090

K23AR059199 (U.S. NIH Grant/Contract)

140857

Details and patient eligibility

About

Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking. Our proposed study aims to fill these gaps by identifying the prognostic factors which will predict better outcomes of rotator cuff tears, based on both operative and non-operative treatment. The investigators will also compare outcomes of operative and non-operative treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.

Full description

Rotator cuff tears account for over one quarter million surgeries annually. They are a leading cause of shoulder pain and disability. Patients with rotator cuff tears present with shoulder pain and/or limitation in range of motion. Fourteen special physical exam tests have been described for diagnosis of rotator cuff tears. Prior literature describing sensitivity and specificity of these tests in diagnosing cuff tears is limited by retrospective design, small sample sizes, samples restricted to patients undergoing surgery, and failure to differentiate between partial and full thickness tears. As a result, there is little evidence to help clinicians interpret the diagnostic value of the clinical exam. Consequently, clinicians rely heavily on magnetic resonance imaging (MRI) for diagnosing cuff tears, adding considerable expense in the diagnostic process.

The treatment options for rotator cuff tears are operative and non-operative. There is currently little consensus on indications and timing of rotator cuff surgery or non-operative treatment. Furthermore, there is lack of evidence-based guidance on factors associated with outcomes of operative versus non-operative treatment for cuff tears.

We are enrolling patients in a prospective cohort study to assess comparative-effectiveness of operative versus non-operative treatment of rotator cuff tears and understand prognostic factors for better outcomes after surgery and non-operative treatments.

Enrollment: 400 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 45 or older
• Symptoms for at least 4 weeks of shoulder pain and/or limitation in range of motion of shoulder

Exclusion criteria

• History of humeral fractures
• Prior surgery on the same shoulder
• Contraindications to MRI (prior surgical hardware, pacemakers, defibrillators, and claustrophobia)
• Unable or unwilling to give informed consent
• Unable or unwilling to be followed up
• Non-English speaking (as questionnaires have only been validated in English)