Functional and radiological outcome of non-surgical vs surgical treatment for the atraumatic cuff rupture after 1 year (COPACABANA trial).
- Conditions
- atraumatic (atraumatisch)rotator cuff rupture (rotator cuff ruptuur)subacromial impingement syndrome (impingement syndroom)shoulder (schouder)
- Registration Number
- NL-OMON26949
- Lead Sponsor
- MCGMartini Hospital Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 108
In all patients referred to the department of Orthopaedic surgery and Rehabilitation of both the Martini Hospital and the University Medical Centre in Groningen, aged between 45 en 75 years, with a clinically suspected atraumatic rotator cuff rupture a MRI scan will be performed. If on the MRI of the affected shoulder 2 independent assessors diagnose a full thickness rotator cuff rupture with degenerative characteristics, the patient will be included in this study.
Exclusion criteria are traumatic rotator cuff rupture, no signs of degeneration on MRI, previous surgical treatment of the shoulder, frozen shoulder, radiological and symptomatic osteoarthritis of the gleno-humeral or acromio-clavicular joint, (rheumatoid) arthritis, diabetes mellitus and cognitive disorders, neurological disease or language barriers impairing participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional outcome is the primary outcome measurement. The Constant Murley Score will be used. This score system combines a shoulder function test (65 points) with a subjective evaluation of complaints by the patient (35 points). The Constant Murley Score is a valid score for shoulder function and rotator cuff ruptures and repairs.
- Secondary Outcome Measures
Name Time Method Secondary outcome measurements are the Dutch Simple Shoulder Test, the Visual Analog Scale for pain and restriction, the Goutallier score, anatomical localization of the rotator cuff rupture, integrity of the rotator cuff and economic evaluation.