Status:
COMPLETED
InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
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™ in the study population in comparison to surgical RCT repair.
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 MRI of the affected shoulder indicating full thickness large to massive RCT of at least 3cm in diameter (according to Cofield classification2) involving one or more tendons. (MRI can be done up to 6 months prior to randomization.)
- 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 :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02210910
Start Date
June 1 2012
End Date
April 1 2018
Last Update
August 22 2018
Active Locations (1)
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1
Assuta Medical Center
Tel Aviv, Israel, 60710