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
  Purpose

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 Intervention
Rotator Cuff Tear
Procedure: Immobilization

Study Type: Observational
Study Design: 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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • repair integrity analysis using postoperative MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American Shoulder and Elbow Surgeons' score [ Time Frame: 2 year postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Immobilization
    compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891566

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

Publications:
Additional 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
Study First Received: April 29, 2009
Last Updated: May 23, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

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

ClinicalTrials.gov processed this record on September 18, 2014