Rotator Cuff Tear Clinical Trial
Official title:
Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial
The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 2017 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Trauma to the shoulder - Full thickness cranial rotator cuff tear - Operation possible within 3 months Exclusion Criteria: - 2 or more rotator cuff tendons involved - Fracture - Dislocation - Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor) - Malignancy - Rheumatic disease - Inability to understand swedish - Substance abuse |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Orthopedic Clinic, Linköping University Hospital | Linköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Euro-Qol-five-Dimensions (EQ-5D) | Quality of life assessment | Twelve months | No |
Other | Patient Global Impression of Change (PGIC) | Patients Global impression of Change | Twelve months | No |
Primary | Constant-Murley Shoulder Assessment score | Twelve months | No | |
Secondary | Western Ontario Rotator Cuff score | Shoulder specific, patient reported outcome score | Twelve months | No |
Secondary | MRI | Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture. | Twelve months | No |
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