Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
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|ClinicalTrials.gov Identifier: NCT00290888|
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : May 9, 2014
Last Update Posted : March 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear Shoulder Impingement Syndrome||Procedure: Acromioplasty||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Active Comparator: ACR
Arthroscopic rotator cuff repair without acromioplasty
Arthorscopic rotator cuff repair with acromioplasty
- Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 24 months ]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 ]Calculated as a percentage with an increase in score reflecting an improvement in outcome.
- Shoulder Range of Motion [ Time Frame: 24 months ]
- Upper Extremity Strength Grading [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290888
|Winnipeg, Manitoba, Canada, R3M 3E4|
|Principal Investigator:||Peter MacDonald, MD, FRCS(C)||Panam Clinic Orthopedics and Sports Medicine/University of Manitoba|