A prospective, single blinded, multi-center, randomized, controlled, pivotal study to assess the safety and effectiveness of the InSpace device for treatment of full thickness Massive Rotator Cuff Tears
A study assessing the study device, InSpace device, for treatment of massive rotator cuff tears
Sponsor: Ortho-Space Ltd.
Enrolling: Male and Female Patients
Study Length: 48 Months
Clinic Visits: 8
IRB Number: AAAR1045
U.S. Govt. ID: NCT02493660
Contact: Nicole Skursky: 646-317-2940 / ns3197@cumc.columbia.edu
Additional Study Information: The study is designed to evaluate the safety and effectiveness of the InSpace device as a primary surgical treatment for a full thickness Massive Rotator Cuff Tears (MRCT) in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
This study is closed
Investigator
William Levine, MD
Do You Qualify?
Do you have a full-thickness or complete tear or your rotator cuff? Yes No
Have you had previous shoulder surgery in the past 1 year? Yes No
Is your condition affecting both shoulders and rotator cuff repair is scheduled or to be scheduled? Yes No
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For more information, please contact:
Nicole Skursky
ns3197@cumc.columbia.edu
646-317-2940
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