Superior capsular reconstruction of irreparable degenerative rotator cuff tears of the shoulder: a multi-center,comparative, prospective, observational follow-up study
Completed
- Conditions
- degenerative rotator cuff tear1004323710005944wear and tear shoulder tendon
- Registration Number
- NL-OMON48664
- Lead Sponsor
- Viecuri Medisch Centrum voor Noord-Limburg
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion Criteria
Age > 40 years;
Patiënts with a clinical suspicion of a rotator cuff tear scheduled for
arthroscopic superior capsular reconstruction;
Patients have signed informed consent.
Exclusion Criteria
Patients with rheumatoid arthritis
The inability to understand Dutch language
Patients with neurologic impairment influencing functioning affected limb
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the functional outcome, measured using the<br /><br>Constant-Murley score (including a patient questionnaire and measurements of<br /><br>Range of Motion and muscular strength).<br /><br>This will be measured pre-operatively and at 3, 6, 12 and 24 months<br /><br>post-operatively as well as 5 and 10 years post-operatively.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Furthermore, pain (NRS-score), function (Disabilities of Arm Shoulder and Hand<br /><br>(DASH) questionnaire) and quality of life (SF12) will be measured and X-rays<br /><br>will be taken to evaluate possible (re)tears.<br /><br>All parameters will be measured pre-operatively and at 3, 6, 12 and 24 months<br /><br>post-operatively, as well as 5 and 10 years post-operatively. Only the<br /><br>radiographs at 3 months will not discarded, since an X-ray is already taken<br /><br>directly post-opeartive, conform standard care.</p><br>