Debridement vs debridement and biodegradable balloon

• 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.

• 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.