- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00290888
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3M 3E4
- Panam Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages 18 or older
- Complete rotator cuff tear up to 4 cm in size
- Persistent pain and functional disability for at least 6 months
- Failure of conservative treatment
- Establishment of final eligibility based upon visual exam of rotator cuff tear during surgery and determination of repairability
Exclusion Criteria:
- Evidence of significant osteoarthritis or cartilage damage in the shoulder
- Evidence of glenohumeral instability including Bankart lesions and labral tears of any type
- Previous surgeries of the shoulder
- Evidence of major joint trauma, infection, or necrosis in the shoulder
- Patients with partial thickness tears of the rotator cuff
- Patients unable to provide informed consent due to language barrier or mental status
- Patients with a major medical condition that would affect quality of life and influence the results of the study
- Patients with worker compensation claims
- Patients unwilling to be followed for the duration of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ACR
Arthroscopic rotator cuff repair without acromioplasty
|
|
Experimental: ACR-A
Arthorscopic rotator cuff repair with acromioplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Ontario Rotator Cuff Index (WORC)
Time Frame: 24 months
|
Calculated as percentage with an increase in score indicating an improvement in outcome.
|
24 months
|
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Time Frame: 24 months
|
Calculated as a percentage with an increase in score reflecting an improvement in outcome.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shoulder Range of Motion
Time Frame: 24 months
|
24 months
|
Upper Extremity Strength Grading
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter MacDonald, MD, FRCS(C), Panam Clinic Orthopedics and Sports Medicine/University of Manitoba
Publications and helpful links
General Publications
- Budoff JE, Nirschl RP, Guidi EJ. Debridement of partial-thickness tears of the rotator cuff without acromioplasty. Long-term follow-up and review of the literature. J Bone Joint Surg Am. 1998 May;80(5):733-48. doi: 10.2106/00004623-199805000-00016. No abstract available.
- Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.
- Esch JC. Arthroscopic subacromial decompression and postoperative management. Orthop Clin North Am. 1993 Jan;24(1):161-71.
- Levy HJ, Gardner RD, Lemak LJ. Arthroscopic subacromial decompression in the treatment of full-thickness rotator cuff tears. Arthroscopy. 1991;7(1):8-13. doi: 10.1016/0749-8063(91)90071-5.
- Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.
- Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
- Baker CL, Liu SH. Comparison of open and arthroscopically assisted rotator cuff repairs. Am J Sports Med. 1995 Jan-Feb;23(1):99-104. doi: 10.1177/036354659502300117.
- Gartsman GM. Arthroscopic assessment of rotator cuff tear reparability. Arthroscopy. 1996 Oct;12(5):546-9. doi: 10.1016/s0749-8063(96)90192-9.
- Miller C, Savoie FH. Glenohumeral abnormalities associated with full-thickness tears of the rotator cuff. Orthop Rev. 1994 Feb;23(2):159-62.
- Gartsman GM, Taverna E. The incidence of glenohumeral joint abnormalities associated with full-thickness, reparable rotator cuff tears. Arthroscopy. 1997 Aug;13(4):450-5. doi: 10.1016/s0749-8063(97)90123-7.
- Bokor DJ, Hawkins RJ, Huckell GH, Angelo RL, Schickendantz MS. Results of nonoperative management of full-thickness tears of the rotator cuff. Clin Orthop Relat Res. 1993 Sep;(294):103-10.
- Ellman H, Kay SP, Wirth M. Arthroscopic treatment of full-thickness rotator cuff tears: 2- to 7-year follow-up study. Arthroscopy. 1993;9(2):195-200. doi: 10.1016/s0749-8063(05)80374-3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2004:045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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