Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

Study Overview
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Brief Summary
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Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.

Detailed Description
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This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline. Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears

Official Title
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Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Operative
* Procedure: Non-Operative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged =>40 years to <85 years Shoulder pain and/or loss of range of active motion, strength or function MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification Ability and willingness to provide informed consent Exclusion Criteria: Primary diagnosis is something other than a rotator cuff tear History (in last 2 years) of shoulder fracture involving the humeral head on affected side Previous rotator cuff surgery on affected side Isolated subscapularis &/or teres minor tear on affected side Acute rotator cuff tear caused by a severe trauma Shoulder used as a weight-bearing joint Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.) Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD Grade 4 fatty infiltration of rotator cuff (any tendons) Candidate for shoulder arthroplasty at baseline Non-English speaking

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative<br>surgery + post-operative physical therapy | Procedure: Operative<br>* Arthroscopic rotator cuff surgery followed by physical therapy.<br>|
| Active Comparator: Non-Operative<br>non-operative physical therapy | Procedure: Non-Operative<br>* Physical therapy (without surgery).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain & Disability Index (SPADI) | SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst. | Study participants will be followed for 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons (ASES) | ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best. | Study participants will be followed for 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroscopy, physical therapy, rehabilitation, surgery, rotator cuff tear