Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff|
- Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 24 months ] [ Designated as safety issue: No ]Calculated as percentage with an increase in score indicating an improvement in outcome.
- American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) [ Time Frame: 24 months ] [ Designated as safety issue: No ]Calculated as a percentage with an increase in score reflecting an improvement in outcome.
- Shoulder Range of Motion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Upper Extremity Strength Grading [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Active Comparator: ACR
Arthroscopic rotator cuff repair without acromioplasty
Arthorscopic rotator cuff repair with acromioplasty
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290888
|Winnipeg, Manitoba, Canada, R3M 3E4|
|Principal Investigator:||Peter MacDonald, MD, FRCS(C)||Panam Clinic Orthopedics and Sports Medicine/University of Manitoba|