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Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00891566
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Rotator Cuff Tear Procedure: Immobilization

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial
Study Start Date : April 2008
Primary Completion Date : June 2010
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: Immobilization
    compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair

Outcome Measures

Primary Outcome Measures :
  1. repair integrity analysis using postoperative MRI [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. American Shoulder and Elbow Surgeons' score [ Time Frame: 2 year postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
medium to large size rotator cuff tears
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891566


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jae Chul Yoo, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00891566     History of Changes
Other Study ID Numbers: 2008-04-051
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: May 2011

Keywords provided by Samsung Medical Center:
medium to large tear
rotator cuff tear
arthroscopic repair
repair integrity
immobilization

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries