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
Status: Completed
Location: See all (21) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 100
Healthy Volunteers: f
View:
• Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)
• Functional deltoid muscle and preserved passive range of motion on physical examination
• Documented VAS score of \> 30 mm pain
• Failed non-operative treatment of at least 4 months
• Patient in general good health,independent, and can comply with all post-operative evaluations and visits.
Locations
United States
California
Southern California Orthopedic Institute
Van Nuys
Colorado
University of Colorado
Denver
Florida
Holy Cross Hospital
Fort Lauderdale
Illinois
Midwest Orthopedics at RUSH
Chicago
Rockford Orthopedic Associates
Rockford
Louisiana
Tulane University School of Medicine
New Orleans
Massachusetts
Brigham & Women's Hospital
Boston
Maryland
Johns Hopkins
Baltimore
MedStar Union Memorial Orthopaedics
Baltimore
New York
Columbia University Medical Center
New York
NYU
New York
University of Buffalo Buffalo
New York
Upstate Orthopedics
Syracuse
Ohio
Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health
Cincinnati
The Ohio State University
Ohio City
Pennsylvania
Rothman Institute
Philadelphia
University Orthopedic Center
State College
Texas
University of Texas Southwestern Medical Center
Dallas
Other Locations
Canada
Fowler Kennedy Sport Medicine Clinic
London
Roth McFarlane Hand and Upper Limb Center
London
Ottawa Hospital Research Institute
Ottawa
Time Frame
Start Date: 2015-06-26
Completion Date: 2020-03-17
Participants
Target number of participants: 184
Treatments
Experimental: InSpace implantation
Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation
Active_comparator: Tendon Repair
Arthroscopic partial repair of rotator cuff
Authors
Brian Cole, Michael Bahk, Laurence Higgins, John Tokish, Gregory Nicholson, William Levine, Robert Meislin, Stephen Snyder, Jonathan Bravman, Nikhil Verma, William Tyndall, Jonathan Levy, Jason Koh, Kevin Setter, Joseph Abboud, Diego Villacis, Eric McCarty, Matthew DiPaola, Scott Trenhaile, Michael Kissenberth, Anand Murthi, Michael Khazzam, Paul Sensiba, Mark Getelman, Robert Litchfield, Kenneth Faber, George Athwal, Peter Lapner
Related Therapeutic Areas
Sponsors
Leads: OrthoSpace Ltd.