Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty

Study Overview
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Brief Summary
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Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. However, an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty, but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament. This prospective study examines the hypothesis that appropriate shoulder function can be restored through the execution of the traditional arthroscopic cuff repair without acromioplasty.

Detailed Description
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There exists some controversy in the current trend in repair of full thickness tears of the rotator cuff. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. The purpose of acromioplasty is to create adequate space for the rotator cuff tendons. Arthroscopic acromioplasty involves the removal of the subacromial bursa, resection of the coracoacromial ligament and anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement. However, acromioplasty without cuff repair has been reported to have both good and poor results, showing that the technique may be suspect in repair of full thickness tears alone. The purpose of this study is to compare the effectiveness of arthroscopic cuff repair with acromioplasty to arthroscopic cuff repair without acromioplasty in repair of full thickness tears of the rotator cuff. We hypothesize that there will be a significant clinical improvement in quality of life in patients who receive a rotator cuff repair without acromioplasty compared to those who receive a cuff repair with acromioplasty.

Official Title
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Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff

Conditions
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Rotator Cuff Tear, Shoulder Impingement Syndrome

Intervention / Treatment
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* Procedure: Acromioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 or older Complete rotator cuff tear up to 4 cm in size Persistent pain and functional disability for at least 6 months Failure of conservative treatment Establishment of final eligibility based upon visual exam of rotator cuff tear during surgery and determination of repairability Exclusion Criteria: Evidence of significant osteoarthritis or cartilage damage in the shoulder Evidence of glenohumeral instability including Bankart lesions and labral tears of any type Previous surgeries of the shoulder Evidence of major joint trauma, infection, or necrosis in the shoulder Patients with partial thickness tears of the rotator cuff Patients unable to provide informed consent due to language barrier or mental status Patients with a major medical condition that would affect quality of life and influence the results of the study Patients with worker compensation claims Patients unwilling to be followed for the duration of the study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACR<br>Arthroscopic rotator cuff repair without acromioplasty | Procedure: Acromioplasty<br> <br> |
| Experimental: ACR-A<br>Arthorscopic rotator cuff repair with acromioplasty | Procedure: Acromioplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff Index (WORC) | Calculated as percentage with an increase in score indicating an improvement in outcome. | 24 months | 
| American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) | Calculated as a percentage with an increase in score reflecting an improvement in outcome. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Range of Motion |  | 24 months | 
| Upper Extremity Strength Grading |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Tear, Tendon Repair, Acromioplasty, Arthroscopy, Orthopedic Surgery