Status:
TERMINATED
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
Lead Sponsor:
OrthoSpace Ltd.
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
40-95 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Main 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02211183
Start Date
August 1 2014
End Date
February 1 2016
Last Update
April 6 2018
Active Locations (1)
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1
Fundacion Jimenez Diaz
Madrid, Spain, 28040