All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears

Study Overview
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Brief Summary
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This study will compare two different surgical techniques for repairing a tear in the muscles of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or mini-open technique provides better quality of life and repair integrity.

Detailed Description
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Background: Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair. Methods/Design: This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate sized rotator cuff tears. A national consensus meeting of investigators in Joints Orthopaedic Initiative for Shoulder Trials (JOINTS) identified this question as the top priority for shoulder surgeons across Canada. The primary outcome measure is a valid quality-of-life scale (Western Ontario Rotator Cuff (WORC) that addresses 5 domains of health affected by rotator cuff disease. Secondary outcomes will assess rotator cuff functionality (ROM, strength, constant score), secondary dimensions of health (general health status (SF-12) and work limitations) and repair integrity (MRI). Outcomes are measured at baseline, at 6 weeks, 3, 6, 12 and 24 months postoperatively by blinded research assistants and musculoskeletal radiologists. Patients (n=250) with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited. This sample size will provide 80% power to detect (statistically) a clinically important difference of 20% in WORC scores between procedures after controlling for baseline WORC score (=0.05). A central methods centre will manage randomization, data management and monitoring under supervision of experienced epidemiologists. Surgeons will participate in either conventional or expertise-based designs according to defined criteria, to avoid biases from differential surgeon expertise. Mini-open or all-arthroscopic repair procedures, will be performed according to a standardized protocol. Central Adjudication (of cases), Trial Oversight and Safety Committees will monitor trial conduct. The investigators will use an analysis of covariance (ANCOVA), where the baseline WORC score is used as a covariate, to compare the quality of life (WORC score) at 2-years post-operatively. As a secondary analysis the investigators will conduct the same statistical test but will include age and tear size as covariates with the baseline score. Enrollment will require 2 years and follow-up an additional 2-years.

Official Title
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All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears

Conditions
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Shoulder Pain, Rotator Cuff Tear

Intervention / Treatment
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* Procedure: All-Arthroscopic repair
* Procedure: Mini-open repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The investigators will recruit patients with small or medium rotator cuff tears as determined by clinical examination and diagnostic imaging (magnetic resonance imaging [MRI]) prior to surgery. The full-thickness rotator cuff tears of supraspinatus and infraspinatus will be classified into 2 categories based on area of longest dimension. SMALL= 0-1 cm; MODERATE =1-3 cm. Definitive measurement of tear size will be made in surgery and used as a covariate in analysis. (JOINTS measurement protocol will be used) Exclusion Criteria: Pre-Operative Exclusion Criteria Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder or previous surgery of the affected shoulder, Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations, Major medical illness (life expectancy less then 2 years or unacceptably high operative risk), Unable to speak or read English, Psychiatric illness that precludes informed consent, Unwilling to be followed for 2 years. Intra-Operative Exclusion Criteria Large, massive or irreparable cuff tears, extending into the subscapularis or teres minor, which cannot be mobilized to the articular margin or repaired using one or both of the techniques (all arthroscopic or mini-open), Teres minor or subscapularis tears, Inelastic and immobile tendon, which cannot be advanced to articular margin, Co-existing labral pathologies requiring repair with sutures (superior labral anterior posterior [SLAP] II-IV), Bankart lesions requiring repair, partial tears of biceps (more than 60% of thickness) requiring tenodesis or release.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: 1<br>All-arthroscopic repair | Procedure: All-Arthroscopic repair<br>* joint techniques and repair are both performed entirely through the arthroscope<br>|
| Active Comparator: 2<br>Mini-open repair | Procedure: Mini-open repair<br>* repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC) |  | within 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 |  | within 2 years | 
| Work Limitations Scale |  | within 2 years | 
| Cuff integrity on imaging |  | within 1 year post-operative | 
| Strength |  | within 2 years | 
| Range of Motion |  | within 2 years | 
| American Shoulder and Elbow Surgeons (ASES) shoulder scale |  | within 2 years | 
| Shoulder and Pain Disability Index (SPADI) |  | Within 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder surgery, rotator cuff, arthroscopic repair, mini-open repair