Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

Study Overview
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Brief Summary
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The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.

Detailed Description
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Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies. In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.

Official Title
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Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Tendon repair with acromioplasty
* Procedure: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical history and imaging findings of a rotator cuff tear Exclusion Criteria: Presence of other local or systemic diseases influencing on shoulder function History of earlier rotator cuff surgery Medical contraindications for surgery

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical treatment<br>Open or mini-open tendon repair with acromioplasty | Procedure: Tendon repair with acromioplasty<br>* Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps<br>|
| Active Comparator: Physiotherapy<br>Physiotherapy by exercises | Procedure: Physiotherapy<br>* According to a rehabilitation program which was established prior to study start.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score |  | baseline, 6 months, 1, 2, 5, 10, 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self report section of the American Shoulder and Elbow Surgeons score (ASES) |  | baseline, 6 months, 1, 2, 5, 10, 15 years | 
| Short Form 36 Health Survey (SF-36) |  | baseline, 6 months, 1, 2, 5, 10, 15 years | 
| Patient satisfaction |  | 1, 2, 5, 10, 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator cuff tear, surgical repair, Physiotherapy, Treatment benefit, Surgery