Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact
May 23, 2011 updated by: Samsung Medical Center
Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial
The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff.
The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
medium to large size rotator cuff tears
Description
Inclusion Criteria:
- Medium to large sized cuff tear (2-4 cm)
- Yes subscapular partial fraying or longitudinal split side to side
- Yes acromioplasty
- Yes AC arthritis with mumford procedure
- Yes biceps tenotomy or tenodesis
Exclusion Criteria:
- No arthritic changes of glenohumeral joint
- No combined infection
- No mini-open procedures
- No complete subscapularis tear
- No incomplete repair
- No small tears or side to side repairs without anchors
- No pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
repair integrity analysis using postoperative MRI
Time Frame: 6 months
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
American Shoulder and Elbow Surgeons' score
Time Frame: 2 year postoperatively
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2 year postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pennekamp W, Gekle C, Nicolas V, Seybold D. [Initial results of shoulder MRI in external rotation after primary shoulder dislocation and after immobilization in external rotation]. Rofo. 2006 Apr;178(4):410-5. doi: 10.1055/s-2006-926476. German.
- Lewis CW, Schlegel TF, Hawkins RJ, James SP, Turner AS. The effect of immobilization on rotator cuff healing using modified Mason-Allen stitches: a biomechanical study in sheep. Biomed Sci Instrum. 2001;37:263-8.
- Kim SH, Yoo JC, Ahn JM. Arthroscopically repaired Bankart lesions and the effect of two different arm positions on immediate postoperative evaluation with magnetic resonance arthrography. Arthroscopy. 2005 Jul;21(7):867-74. doi: 10.1016/j.arthro.2005.04.109.
- Koh KH, Lim TK, Shon MS, Park YE, Lee SW, Yoo JC. Effect of immobilization without passive exercise after rotator cuff repair: randomized clinical trial comparing four and eight weeks of immobilization. J Bone Joint Surg Am. 2014 Mar 19;96(6):e44. doi: 10.2106/JBJS.L.01741.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
April 29, 2009
First Submitted That Met QC Criteria
April 30, 2009
First Posted (Estimate)
May 1, 2009
Study Record Updates
Last Update Posted (Estimate)
May 24, 2011
Last Update Submitted That Met QC Criteria
May 23, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-04-051
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.