OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced that enrollment for the U.S. pivotal study evaluating the use of the InSpace™ biodegradable balloon spacer to treat full thickness massive rotator cuff tears (RCTs) has been completed. The prospective, single-blinded, multi-center, randomized, controlled, pivotal IDE study enrolled 184 subjects at 21 sites in the U.S. and Canada.
“We are pleased to report that the InSpace clinical study has reached full accrual as targeted, owing to the strong interest of our investigators and patients in the novel and minimally invasive technology,” said Heather Neill, OrthoSpace’s Vice President of Clinical Operations. “We are grateful to our investigators and their research teams, as well as study participants for their contributions to this clinical study.”
Massive, irreparable rotator cuff tears are associated with severe pain and disability. The InSpace System is deployed in the subacromial space between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones and emulating the function of the original bursa. The arthroscopic procedure typically requires less than 10 minutes to perform.
Nikhil Verma, M.D., Principal Investigator on the study and Professor and Director, Division of Sports Medicine at Rush University Medical Center commented, “Massive rotator cuff repairs represent a major unmet clinical need, and I am pleased to support the development of new technologies for this patient population, which often has few other treatment options.” Dr. Verma continued, “We look forward to presenting clinical results upon completion of follow-up and data analysis.”