Debridement vs debridement and biodegradable balloo
Recruiting
- Conditions
- Shoulder debridement biodegradable balloon rotator cuff tear Schouder debridement , bio-oplosbare ballon, rotator cuff herstel
- Registration Number
- NL-OMON24952
- Lead Sponsor
- Afdeling OrthopaedieHAGA HospitalSportlaan 6002566MJ, Den Haag, Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 104
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 are existing for at least twelve months, despite conservative treatment, including physiotherapy, subacromial infiltration with corticosteroids or anti-inflammatory drugs.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Is there a minimal clinical difference (NRS >2) in pain levels between subjects receiving an arthroscopic debridement with a subacromial bio-absorbable Balloon and solely arthroscopic debridement in subjects with symptomatic irreparable cuff tears after 1 year.
- Secondary Outcome Measures
Name Time Method •Is the progress of pain and functional outcome different and clinically relevant between the two study groups over the period of 1 year?<br /> <br>•What is the percentage of subject satisfaction after 1 year in the two study groups.<br /><br>•What is the percentage and type of complications after 1 year?<br /><br>•To compare survival rates (with endpoint reversed shoulder prosthesis) between both groups after 5 years. <br /><br>•What is the percentage of developing osteoarthritis in the two study groups after 2 years?<br /><br>•What is the position of the balloon after 10 weeks and 6 months and at what point does it loose its volume due to leakage.<br>