Rotator Cuff Rupture Clinical Trial
Official title:
The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial
Verified date | May 2017 |
Source | Lovisenberg Diakonale Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.
Status | Completed |
Enrollment | 120 |
Est. completion date | January 2017 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Lovisenberg Diaconal Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Lovisenberg Diakonale Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint | 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. | One year |
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