Status:
COMPLETED
InSpace™ System Implantation in a Procedure Under Local Anesthesia
Lead Sponsor:
OrthoSpace Ltd.
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualiz...
Detailed Description
A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety of InSpace™ device implantation in a procedure under local anesthesia for a treatment of subjects with massi...
Eligibility Criteria
Inclusion
- Age 50 or older.
- Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).
- Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.
Exclusion
- Known allergy to the balloon material
- Evidence of significant osteoarthritis or cartilage damage in the shoulder
- Evidence of gleno-humeral instability
- Evidence of major joint trauma, infection, or necrosis in the shoulder
- Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
- Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
- Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02208453
Start Date
January 1 2013
End Date
April 1 2019
Last Update
August 28 2019
Active Locations (1)
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1
Hospital of Latisana
Latisana, Udine, Italy, 33503