NL-OMON50270
Recruiting
Not Applicable
Difference in pain and functional outcome after arthroscopic debridement vs. debridement and biodegradable implanted balloon for irreparable rotator cuff tears. - Debridement vs debridement and biodegradable balloon
Reinier Haga Orthopedisch Centrum0 sites104 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- irreparable rupture of the muscles around the shoulder
- Sponsor
- Reinier Haga Orthopedisch Centrum
- Enrollment
- 104
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Subject has an irreparable supra\- and infraspinatus tendon tear confirmed by
- •ultrasound or MRI and is according to the Orthopaedic Surgeon a suitable
- •candidate for debridement.
- •\-The symptoms of the subjects have been there for at least twelve months,
- •despite conservative treatment, including physiotherapy, subacromial
- •infiltration with corticosteroids or anti\-inflammatory drugs.
- •\-Subjects are older than 18 years.
Exclusion Criteria
- •\-Subject is not able to complete the daily questionnaires in Dutch.
- •\-Subject, in the opinion of the investigator, is not able to understand this
- •investigation and is not willing and able to perform all study procedures and
- •co\-operate with investigational procedures.
- •\-Subject has glenohumeral osteo\-arthrosis grade 3 and 4 (KELLGREN and LAWRENCE
- •494\-502\).
- •\-Subject has a total subscalpularis tendon tear.
- •\-Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in
- •the last 5 years) or has a psychological disorder that could affect their
- •ability to complete subject reported questionnaires or be compliant with
Outcomes
Primary Outcomes
Not specified
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