INHANCE Stemless Reverse Shoulder IDE
Purpose
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Conditions
- Arthroplasty
- Replacement
- Shoulder
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 who are willing and able to return for follow-up as specified by the study protocol. 5. Individuals who are a minimum age of 22 years at the time of consent. 6. Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.
Exclusion Criteria
- BMI > 40 kg/m2 2. Individuals have active, uncontrolled local infection or systemic infection. 3. Patients who have not reached skeletal maturity, regardless of age. 4. Either preoperatively or intraoperatively and per standard of care medical assessment, bone stock in the proximal humerus or glenoid fossa is determined to be inadequate for supporting the INHANCE humeral stemless components (NOTE: exclusion applies to both arms of the study, i.e., bone stock to be evaluated independent of randomized treatment assignment). 5. Intraoperatively and per treating physician's assessment of bone quality, bone is determined to be too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e. osteoporosis or sclerotic bone, or tumor(s) of the supporting bone structure, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid. 6. Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components. 7. Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component. 8. Revision of a failed hemi, total or reverse shoulder arthroplasty. 9. Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids. 10. Individuals who are bedridden per the Investigator's determination. 11. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months. 12. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims. 13. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements. 14. Patients with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders). 15. Patient has a medical condition with less than 2 years life expectancy. 16. Patients who are known to be pregnant or breastfeeding. 17. Known polyethylene and/or metal sensitivity or allergy. 18. Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months 19. Otherwise determined by the investigator to be medically unsuitable for participation in this study 20. Patient is a member of a vulnerable population (i.e., incarcerated individuals - those incarcerated for at least one month and considered to be an inmate)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 2:1 Randomized (Stemless to Stemmed)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental INHANCE Stemless Reverse |
INHANCE(TM) Stemless Reverse Total Shoulder |
|
|
Active Comparator INHANCE Stemmed Reverse |
INHANCE(TM) Stemmed Reverse Total Shoulder |
|
Recruiting Locations
Orthopedic Center of Palm Beach County
Atlantis, Florida 33462
Atlantis, Florida 33462
Boston Bone & Joint Institute BBJI Formerly BSSC
Waltham, Massachusetts 02451
Waltham, Massachusetts 02451
Trinity Health Grand Rapids
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri 65201
Columbia, Missouri 65201
OrthoCarolina Research Institute Charlotte
Charlotte, North Carolina 28207
Charlotte, North Carolina 28207
Duke Orthopaedics of Raleigh
Raleigh, North Carolina 27609
Raleigh, North Carolina 27609
Crystal Clinic Orthopaedic Center
Akron, Ohio 44333
Akron, Ohio 44333
Lindner Research Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Cleveland Clinic
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Slocum Center for Orthopaedics and Sports Medicine
Eugene, Oregon 97401
Eugene, Oregon 97401
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
Bethlehem, Pennsylvania 18015
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
MTBJ a division of Tennessee Orthaepedic Alliance
Columbia, Tennessee 38401
Columbia, Tennessee 38401
University of Utah
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
More Details
- Status
- Recruiting
- Sponsor
- DePuy Orthopaedics
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.