The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

Study Overview
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Brief Summary
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The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.

Detailed Description
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Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.

Official Title
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The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial

Conditions
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Rotator Cuff Rupture

Intervention / Treatment
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* Device: Simple sling.
* Device: Neutral brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon - Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon. Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair. -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: 3 weeks with simple sling<br>Early motion after arthroscopic rotator cuff repair. | Device: Neutral brace<br> <br> |
| Active Comparator: 6 weeks with neutral brace<br>Delayed motion after arthroscopic rotator cuff repair. | Device: Simple sling.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint | We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator cuff, Rehabilitation