|- candidate number||29094|
|- NTR Number||NTR7317|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-jun-2018|
|- Secondary IDs||T16-106/METC16-095 METCZWH|
|- Public Title||Debridement vs debridement and biodegradable balloon|
|- Scientific Title||Difference in pain and functional outcome after arthroscopic debridement vs debridement and biodegradable implanted balloon for irreparable rotator cuff tears.|
|- Healt Condition(s) or Problem(s) studied||Shoulder 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-jan-2017|
|- planned closingdate|
|- Target number of participants||104|
|- Interventions||Group 1 Arthroscopic debridement |
Group 2 Arthroscopic debridement with implantation of a bio-absorbable Balloon
|- Primary outcome||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||• 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.
|- Timepoints||Subjects are measured preoperative, 3 and 10 weeks postoperative, 6, 12 months and 5 years postoperative|
|- Trial web site|
|- status||open: 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|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||28-jun-2018 - 9-jul-2018|