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Sponsored by: |
Panam Clinic |
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Information provided by: | Panam Clinic |
ClinicalTrials.gov Identifier: | NCT00290888 |
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.
Condition | Intervention |
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Rotator Cuff Tear Shoulder Impingement Syndrome |
Procedure: Acromioplasty |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff |
Estimated Enrollment: | 86 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Manitoba | |
Panam Clinic | |
Winnipeg, Manitoba, Canada, R3M 3E4 |
Principal Investigator: | Peter MacDonald, MD, FRCS(C) | Panam Clinic Orthopedics and Sports Medicine/University of Manitoba |
Study ID Numbers: | B2004:045 |
Study First Received: | February 10, 2006 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00290888 |
Health Authority: | Canada: Health Canada |
Rotator Cuff Tear Tendon Repair Acromioplasty Arthroscopy Orthopedic Surgery |
Lacerations Musculoskeletal Diseases Joint Diseases Shoulder Impingement Syndrome |
Pathologic Processes Disease Syndrome |