- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02050087
The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair
The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Oslo, Norway, 0446
- Lovisenberg Diaconal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -
Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.
Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 3 weeks with simple sling
Early motion after arthroscopic rotator cuff repair.
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Active Comparator: 6 weeks with neutral brace
Delayed motion after arthroscopic rotator cuff repair.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint
Time Frame: One year
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We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint.
We will compare WORC of the early range of motion group to a delayed range of motion group.
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One year
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sigbjørn Dimmen, MD, Phd, Lovisenberg Diaconal Hospital, Oslo, Norway
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/2288
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.
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