Difference in pain and functional outcome after arthroscopic debridement vs. debridement and biodegradable implanted balloon for irreparable rotator cuff tears.

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 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

-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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain measured through a Numeric Rating Scale (NRS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Time until the subjects receive a reversed shoulder prosthesis, if applicable<br /><br>- Functional outcome measured through Oxford Shoulder Score and Total Constant<br /><br>Score.<br /><br>- Radiological outcome measured through Ultrascound and X-ray<br /><br>-Complications</p><br>