InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
Not Applicable
Terminated
- Conditions
- Rotator Cuff Tear
- Registration Number
- NCT02211183
- Lead Sponsor
- OrthoSpace Ltd.
- Brief Summary
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Detailed Description
The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
- Age 40 or older.
- Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
- Persistent pain and functional disability of the affected shoulder for at least 3 months.
Main Exclusion Criteria :
- Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
- Evidence of significant osteoarthritis or cartilage damage in the shoulder
- Evidence of gleno-humeral instability
- Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
- Evidence of major joint trauma, infection, or necrosis in the shoulder
- Partial-thickness tears of the rotator cuff
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The change in Shoulder Score from baseline baseline and 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Fundacion Jimenez Diaz🇪🇸Madrid, Spain