Status:
UNKNOWN
Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis
Lead Sponsor:
University of Western Ontario, Canada
Collaborating Sponsors:
Fowler Kennedy Sport Medicine Clinic
Conditions:
Tendinosis
Shoulder Impingement Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 impingemen...
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...
Eligibility Criteria
Inclusion
- Diagnosis of stage II rotator cuff impingement syndrome defined as:
- Pain referred to the anterior, lateral, or superior shoulder
- Pain exacerbated by overhead and reaching activities
- Positive Neer and/or Hawkins impingement signs
- 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:
- Modification of activities
- The use of analgesic and/or anti-inflammatory medication
- Physiotherapy: Physiotherapy must have included the goal of regaining full range of motion, working towards normal kinematics through increased strength of the rotator cuff muscles. Patients should have obtained range of motion to 80% of the opposite shoulder (assuming this is normal) for each of: internal rotation, external rotation, and forward elevation. A physiotherapy program that involved massage, ultrasound, and/or heat only would not be considered adequate treatment for this study.
- Patients willing to be followed on a regular basis
- Patients 18 years of age and older
Exclusion
- Clinical evidence or history of major joint trauma, infection, surgery, glenohumeral arthritis, or instability.
- Clinical evidence of internal impingement.
- Patients with full-thickness rotator cuff tear as documented on advanced imaging or during surgery.
- Patients with bursal surface tears as documented on advanced imaging or during surgery.
- Patients who are found during surgery to have a partial-thickness tear greater than 50% of tendon thickness.
- Patients with evidence of a lateral down sloping acromion.
- Patients unfit for surgery
- Patients unable to provide informed consent or adequately participate in this study due to a language barrier or psychiatric illness.
- Patients with a major medical illness whose condition or treatment would affect their quality of life and, as such, affect the results of this study.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00196573
Start Date
November 1 2003
End Date
December 1 2014
Last Update
April 25 2014
Active Locations (6)
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1
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
2
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 5P5
3
Pan Am Medical and Surgical Centre
Winnipeg, Manitoba, Canada, R3M 3E4
4
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7