Status:
TERMINATED
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
Lead Sponsor:
OrthoSpace Ltd.
Conditions:
Full-thickness 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
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 . The ef...
Eligibility Criteria
Inclusion
- Main Inclusion Criteria:
- Age 40 or older.
- Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT 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 :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02208440
Start Date
July 1 2014
End Date
January 1 2019
Last Update
June 5 2020
Active Locations (1)
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1
Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery
Wigan, Hall Lane, Appley Bridge, United Kingdom, WN69EP