Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

This study has been completed.

Sponsor:

Information provided by:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT00891566

First received: April 29, 2009

Last updated: May 23, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 29, 2009
Last Updated Date	May 23, 2011
Start Date ^ICMJE	April 2008
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 8, 2009)	repair integrity analysis using postoperative MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00891566 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 8, 2009)	American Shoulder and Elbow Surgeons' score [ Time Frame: 2 year postoperatively ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact
Official Title ^ICMJE	Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	medium to large size rotator cuff tears
Condition ^ICMJE	Rotator Cuff Tear
Intervention ^ICMJE	Procedure: Immobilization compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair
Study Group/Cohort (s)	Not Provided
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. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	100
Completion Date	April 2011
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00891566
Other Study ID Numbers ^ICMJE	2008-04-051
Has Data Monitoring Committee	No
Responsible Party	Jae Chul Yoo, Samsung Medical Center
Study Sponsor ^ICMJE	Samsung Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Samsung Medical Center
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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