irreparable rupture of the muscles around the shoulder massive rotator cuff tears
Conditions
Interventions
The patients will be randomized in a 1: 1 ratio in the two following sub-groups:
Group 1: Subjects will undergo a surgical intervention: arthroscopic
debridement and bicepstenotomie (when there was n
Sponsors
Reinier Haga Orthopedisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured through a Numeric Rating Scale (NRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Time until the subjects receive a reversed shoulder prosthesis, if applicable - Functional outcome measured through Oxford Shoulder Score and Total Constant Score. - Radiological outcome measured through Ultrascound and X-ray -Complications | — |
Countries
Netherlands
Outcome results
None listed