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Debridement vs debridement and biodegradable balloon


- candidate number29094
- NTR NumberNTR7317
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jun-2018
- Secondary IDsT16-106/METC16-095 METCZWH
- Public TitleDebridement vs debridement and biodegradable balloon
- Scientific TitleDifference in pain and functional outcome after arthroscopic debridement vs debridement and biodegradable implanted balloon for irreparable rotator cuff tears.
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedShoulder debridement , Rotator cuff tear, Biodegradable balloon
- 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.
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 follow-up requirements.
Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
Subject has an active elevation of less than 60 degrees (pseudoparalysis).
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
Subject is allergic to the Balloon material
Subject has a medical condition with less than 3 years of life expectancy.
Subject has refused voluntary, written informed consent to participate in this randomized controlled trial.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-jan-2017
- planned closingdate
- Target number of participants104
- InterventionsGroup 1 Arthroscopic debridement
Group 2 Arthroscopic debridement with implantation of a bio-absorbable Balloon
- Primary outcomeIs 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 Is the progress of pain and functional outcome different and clinically relevant between the two study groups over the period of 1 year?
What is the percentage of subject satisfaction after 1 year in the two study groups.
What is the percentage and type of complications after 1 year?
To compare survival rates (with endpoint reversed shoulder prosthesis) between both groups after 5 years.
What is the percentage of developing osteoarthritis in the two study groups after 2 years?
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.
- TimepointsSubjects are measured preoperative, 3 and 10 weeks postoperative, 6, 12 months and 5 years postoperative
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES I.C.E. Bouman
- CONTACT for SCIENTIFIC QUERIES I.C.E. Bouman
- Sponsor/Initiator Haga Hospital, Department of Orthopedics
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD28-jun-2018 - 9-jul-2018


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