Superior Capsule vs Bridging Study

Study Overview
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Brief Summary
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Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in irreparable rotator cuff tears.

Detailed Description
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RCT n = 50 Groups: bridging SCR Outcomes: WORC ASES QuickDASH MRI at 12 months post-op

Official Title
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Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Procedure: SCR
* Procedure: Bridging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively) Either primary tear or re-tear after previous repair Radiographic evidence of Hamada stage 1-3, with or without Samilson & Prieto mild osteoarthritis (<3mm inferior osteophyte) Exclusion Criteria: Primary glenohumeral osteoarthritis: radiographic evidence of Samilson & Prieto classification moderate or greater Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis) Medical issues precluding surgery Unwilling or unable to complete study outcomes Worker's Compensation Claim or litigation

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bridging<br>Tendon repair with graft interposition | Procedure: Bridging<br>* Tendon repair with graft interposition<br>|
| Experimental: SCR<br>Superior Capsule reconstruction | Procedure: SCR<br>* Superior Capsule reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeon Outcome - patient portion | American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100) | 24 months | 
| American Shoulder and Elbow Surgeon Outcome - patient portion | American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100) | 12 months | 
| American Shoulder and Elbow Surgeon Outcome - patient portion | American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100) | 6 months | 
| American Shoulder and Elbow Surgeon Outcome - patient portion | American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff Index | Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100) | 24 months | 
| Western Ontario Rotator Cuff Index | Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100) | 12 months | 
| Western Ontario Rotator Cuff Index | Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100) | 6 months | 
| Western Ontario Rotator Cuff Index | Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100) | 3 months | 
| Disabilities of the Arm, Shoulder and Hand - QuickDASH | Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0) | 24 months | 
| Disabilities of the Arm, Shoulder and Hand - QuickDASH | Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0) | 12 months | 
| Disabilities of the Arm, Shoulder and Hand - QuickDASH | Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0) | 6 months | 
| Disabilities of the Arm, Shoulder and Hand - QuickDASH | Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0) | 3 months | 
| Tendon healing, assessed via MRI | Tendon healing (classifications: intact or retorn) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irreparable