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Sponsored by: |
Fowler Kennedy Sport Medicine Clinic |
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Information provided by: | Fowler Kennedy Sport Medicine Clinic |
ClinicalTrials.gov Identifier: | NCT00196573 |
The purpose of this study is to compare the effectiveness of arthroscopic subacromial decompression (acromioplasty) to arthroscopic subacromial bursectomy (no acromioplasty) in rotator cuff impingement syndrome.
The investigators' hypothesis is that arthroscopic subacromial decompression provides no additional benefit, as evaluated with disease specific quality of life measures, compared to arthroscopic bursectomy.
Condition | Intervention | Phase |
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Tendinosis Shoulder Impingement Syndrome |
Procedure: Shoulder arthroscopy including bursectomy +/- acromioplasty |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 114 |
Study Start Date: | November 2003 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of stage II rotator cuff impingement syndrome defined as:
Failure of 6 months of conservative treatment. Failed conservative treatment will be defined as persistent pain and disability despite adequate non-operative management for 6 months. Non-operative management will be defined as:
Exclusion Criteria:
Contact: Elizabeth Wambolt, BSc (HK), CCRP | (519) 661-2111 ext 87528 | ewambolt@uwo.ca |
Canada, Alberta | |
University of Calgary Sport Medicine Centre | Recruiting |
Calgary, Alberta, Canada, T2N 1N4 | |
Principal Investigator: Robert Hollinshead, MD, FRCS(C) | |
Sub-Investigator: Laurie Hiemstra, MD, FRCS(C) | |
Canada, British Columbia | |
Royal Columbian Hospital | Recruiting |
New Westminster, British Columbia, Canada, V3L 5P5 | |
Principal Investigator: Robert McCormack, MD, FRCS(C) | |
Canada, Manitoba | |
Pan Am Medical and Surgical Centre | Recruiting |
Winnipeg, Manitoba, Canada, R3M 3E4 | |
Principal Investigator: Peter MacDonald, MD, FRCS(C) | |
Sub-Investigator: Jamie Dubberly, MD, FRCS(C) | |
Canada, Ontario | |
Hand and Upper Limb Clinic | Recruiting |
London, Ontario, Canada, N6A 4L6 | |
Sub-Investigator: Ken Faber, MD, FRCS(C) | |
Orthopaedic and Arthritic Hospital | Recruiting |
Toronto, Ontario, Canada, M4Y 1H1 | |
Principal Investigator: Richard Holtby, MD, FRCS(C) | |
Fowler Kennedy Sport Medicine Clinic | Recruiting |
London, Ontario, Canada, N6A 3K7 | |
Contact: Elizabeth Wambolt, BSC (HK), CCRP (519) 661-2111 ext 87528 ewambolt@uwo.ca | |
Principal Investigator: Kevin Willits, MD, FRCS(C) | |
Sub-Investigator: Robert Litchfield, MD, FRCS(C) |
Principal Investigator: | Kevin Willits, MD, FRCS(C) | Fowler Kennedy Sport Medicine Clinic |
Study ID Numbers: | FKSMC-AOSSM-1, WillitsYIG1 |
Study First Received: | September 12, 2005 |
Last Updated: | January 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00196573 History of Changes |
Health Authority: | Canada: Health Canada |
Rotator Cuff Tendinosis Impingement Syndrome |
Partial Thickness Tears Rotator Cuff Tendinosis Partial Thickness Rotator Cuff Tears |
Lacerations Tendinopathy Tendon Injuries Muscular Diseases Musculoskeletal Diseases |
Joint Diseases Wounds and Injuries Disorders of Environmental Origin Shoulder Impingement Syndrome |
Tendinopathy Tendon Injuries Muscular Diseases Pathologic Processes Disease Musculoskeletal Diseases |
Joint Diseases Syndrome Wounds and Injuries Disorders of Environmental Origin Shoulder Impingement Syndrome |