Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis
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|ClinicalTrials.gov Identifier: NCT00196573|
Recruitment Status : Unknown
Verified April 2014 by Dianne Bryant, University of Western Ontario, Canada.
Recruitment status was: Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : April 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tendinosis Shoulder Impingement Syndrome||Procedure: Shoulder bursectomy alone||Phase 3|
The most commonly performed surgical procedure to treat rotator cuff tendinosis, when no full-thickness tear exists, is subacromial decompression (acromioplasty). This procedure is based on the theory that primary acromial morphology, (an extrinsic cause), is the initiating factor leading to the dysfunction and eventual tearing of the rotator cuff.
Subacromial decompression involves surgical excision of the subacromial bursa, resection of the coracoacromial ligament, resection of the anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement.
Several studies have indicated that the vast majority of partial-thickness tears are found on the articular surface of the rotator cuff which is not in keeping with the theory that rotator cuff impingement is primarily a result of acromion morphology.
Burkhart proposed that pathologic changes in the supraspinatus tendon occur primarily as a result of overuse and tension overload (an intrinsic factor), resulting in superior migration of the humeral head during active elevation.
Budoff et al., suggest that since the coracoacromial ligament stabilizes the rotator cuff to prevent uncontrolled superior migration of the humeral head, resection of the coracoacromial ligament during arthroscopic subacromial decompression may cause, in the long-term, additional proximal migration of the humeral head.
Arthroscopic bursectomy with debridement of rotator cuff tears alone, without acromioplasty, addresses the primary anatomical pathology and may offer similar success rates to subacromial decompression, without the risk of future instability caused by resection of the acromion and coracoacromial ligament.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial Comparing the Effectiveness of Subacromial Decompression (Acromioplasty) Versus Subacromial Bursectomy (no Acromioplasty) in the Arthroscopic Treatment of Patients With Rotator Cuff Tendinosis|
|Study Start Date :||November 2003|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
|Active Comparator: Shoulder bursectomy and acromioplasty||Procedure: Shoulder bursectomy alone|
- The Western Ontario Rotator Cuff (WORC) index [ Time Frame: Baseline, 2 & 6 weeks, 3, 6, 12, 18, 24 months ]a disease specific quality of life measure for rotator cuff disease evaluated pre-operatively and at all post-operative visits
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): NCT00196573
|University of Calgary Sport Medicine Centre|
|Calgary, Alberta, Canada, T2N 1N4|
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 5P5|
|Pan Am Medical and Surgical Centre|
|Winnipeg, Manitoba, Canada, R3M 3E4|
|Fowler Kennedy Sport Medicine Clinic|
|London, Ontario, Canada, N6A 3K7|
|Hand and Upper Limb Clinic|
|London, Ontario, Canada, N6A 4L6|
|Orthopaedic and Arthritic Hospital|
|Toronto, Ontario, Canada, M4Y 1H1|
|Principal Investigator:||Kevin Willits, MD, FRCS(C)||Fowler Kennedy Sport Medicine Clinic|