Rotator Cuff Tear Clinical Trial
Official title:
A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
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 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 improvement of range of motion (ROM). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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Phase 2/Phase 3 | |
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||
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||
| Completed |
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Phase 4 | |
| Completed |
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Phase 2 | |
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Phase 4 | |
| Completed |
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|
N/A | |
| Completed |
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N/A | |
| Terminated |
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Phase 1 | |
| Completed |
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N/A | |
| Completed |
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| Completed |
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N/A | |
| Active, not recruiting |
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Phase 4 | |
| Recruiting |
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