Status:
TERMINATED
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
Lead Sponsor:
OrthoSpace Ltd.
Conditions:
Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
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 . The ef...
Eligibility Criteria
Inclusion
- Main Inclusion Criteria:
- Age 40 or older.
- Positive diagnostic imaging (CT arthrogram or MRI)\* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W\>2cm and L\>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) 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 :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01890733
Start Date
September 1 2012
End Date
September 1 2015
Last Update
June 4 2020
Active Locations (1)
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1
Policlinico
Milan, Italy