Full-thickness 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 .
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 shoulder outcome scores of each treatment
arm ( ASES, Constant and Quick DASH) from pre-operation (baseline) up to 2 years
post-operation, with respect to pain reduction, improvement of activity of daily living (ADL)
and improvement of range of motion (ROM).
The safety will be asses by comparing the Adverse event rate between the treatment arms.
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