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

April 29, 2009
May 23, 2011
April 2008
June 2010   (final data collection date for primary outcome measure)
repair integrity analysis using postoperative MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00891566 on ClinicalTrials.gov Archive Site
American Shoulder and Elbow Surgeons' score [ Time Frame: 2 year postoperatively ] [ Designated as safety issue: No ]
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Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact
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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

medium to large size rotator cuff tears

Rotator Cuff Tear
Procedure: Immobilization
compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00891566
2008-04-051
No
Jae Chul Yoo, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP