Treatment of Small Acute Cuff Tears, a Randomized Study

Study Overview
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Brief Summary
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The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.

Detailed Description
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In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery. This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair. Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.

Official Title
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Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Rotator cuff repair
* Procedure: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma to the shoulder Full thickness cranial rotator cuff tear Operation possible within 3 months Exclusion Criteria: 2 or more rotator cuff tendons involved Fracture Dislocation Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor) Malignancy Rheumatic disease Inability to understand swedish Substance abuse
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 |
| --- | --- |
| Experimental: Physiotherapy & Surgery<br>Mini-open rotator cuff repair | Procedure: Rotator cuff repair<br>* Physiotherapy & Surgery<br>Procedure: Physiotherapy<br> <br> |
| Active Comparator: Physiotherapy<br>Structured physiotherapy | Procedure: Physiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley Shoulder Assessment score |  | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff score | Shoulder specific, patient reported outcome score | Twelve months | 
| MRI | Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture. | Twelve months |