Trials / Unknown
UnknownNCT00196573
Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- Sponsor
- University of Western Ontario, Canada · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Shoulder bursectomy alone |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2005-09-20
- Last updated
- 2014-04-25
Locations
6 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00196573. Inclusion in this directory is not an endorsement.