INHANCE Stemless Reverse Shoulder IDE
Start Date
3/4/2025
Completion Date
10/30/2028
Summary
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Detailed Description
There is one primary effectiveness endpoint and there are three primary safety endpoints: 1. Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative 2. Primary safety endpoint(s): 1. No revision, removal, reoperation, supplemental fixation, or other intervention for any system component 2. No humeral or glenoid radiolucent line \>2 mm is present in 50% or more zones at 2 years 3. No conclusive evidence of migration and tilt (\>5mm migration and \>10° tilt) of the humeral or glenoid component at 2 years The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant difference is seen on any of the 3 primary safety endpoints.
Eligibility Criteria
Age Range: 22 years to No maximum
Interventions
Reverse Total Shoulder
Conditions
Locations
Hoag Orthopedic Institute
Irvine, California 92618
United States
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Orthopedic Center of Palm Beach County
Atlantis, Florida 33462
United States
Hospital for Special Surgery
West Palm Beach, Florida 33401
United States
Boston Bone & Joint Institute BBJI Formerly BSSC
Waltham, Massachusetts 02451
United States
Trinity Health Grand Rapids
Grand Rapids, Michigan 49503
United States
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri 65201
United States
OrthoCarolina Research Institute Charlotte
Charlotte, North Carolina 28207
United States
Duke Orthopaedics of Raleigh
Raleigh, North Carolina 27609
United States
Crystal Clinic Orthopaedic Center
Akron, Ohio 44333
United States
Lindner Research Center
Cincinnati, Ohio 45219
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Slocum Center for Orthopaedics and Sports Medicine
Eugene, Oregon 97401
United States
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United States
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania 19107
United States
MTBJ a division of Tennessee Orthaepedic Alliance
Columbia, Tennessee 38401
United States
TOSH- The Orthopedic Specialty Hospital
Murray, Utah 84107
United States
University of Utah
Salt Lake City, Utah 84108
United States
Mary Washington Orthopedics in affiliation with FOA
Fredericksburg, Virginia 22408
United States