Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV Clinical Trial
Official title:
A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Efficacy and Safety of InSpace™ Device in Comparison to 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).
n/a