Operative Versus Non-operative Management of Rotator Cuff Tear

Study Overview
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Brief Summary
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This study aims at determining the effectiveness and cost-effectiveness of surgical management of full-thickness rotator cuff tears compared to conservative treatment. The research setting is prospective, randomised, and controlled. The aim of the study is to search out evidence based data of indications for rotator cuff repair. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when rotator cuff tear is suspected. The investigators hypothesize that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.

Detailed Description
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Subgroup analyses: age sex duration of symptoms presence of trauma before symptoms size of tear degenerative findings other findings in MRI or arthroscopy type of operation co-morbidities occupation pain (VAS) objective shoulder function activities of daily living

Official Title
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The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Rotator cuff repair
* Procedure: Conservative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 35 years old duration of symptoms at least three months despite of non-operative treatment the patient accepts both treatment options (operative and conservative) a full-thickness rotator cuff tear in MRI arthrography Exclusion Criteria: previous shoulder operations too high risk for operation any disease or social problem reducing the ability to co-operate rheumatoid arthritis severe arthrosis of the glenohumeral or acromioclavicular joint irreparable rotator cuff tear (including rotator cuff tear arthropathy) progressive malign disease adhesive capsulitis high-energy trauma before symptoms cervical syndrome shoulder instability

Ages Eligible for Study
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Minimum Age: 35 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: Rotator cuff repair<br>Surgery following a 3 months period of active non-operative treatment | Procedure: Rotator cuff repair<br>* Rotator cuff repair + physical therapy according to a standardized protocol<br>* Other names: Arthroscopic or open rotator cuff repair;|
| Active Comparator: Conservative treatment<br>Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment | Procedure: Conservative treatment<br>* Physiotherapy according to a standardized protocol<br>* Other names: Non-operative treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 3 months | 
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 6 months | 
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 12 months | 
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Rotator cuff, Arthroscopic surgery, Open surgery, Physiotherapy, Physical therapy, Effectiveness, cost-effectiveness