Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
DePuy Orthopaedics
Summary
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
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 suc…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy). 2. Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle. 3. Individuals who are able to read and comprehend the informed patient consent document and are willing and able to provide informed patient consent for participation in the study and have authorized the transfer of their information to DePuy Synthes. 4. Individuals…
Interventions
- DeviceReverse Total Shoulder
Uncemented Reverse Total Shoulder
Locations (19)
- Hoag Orthopedic InstituteIrvine, California
- Cedars Sinai Medical CenterLos Angeles, California
- Orthopedic Center of Palm Beach CountyAtlantis, Florida
- Hospital for Special SurgeryWest Palm Beach, Florida
- Boston Bone & Joint Institute BBJI Formerly BSSCWaltham, Massachusetts
- Trinity Health Grand RapidsGrand Rapids, Michigan