INHANCE Stemless Reverse Shoulder IDE
Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
- Arthroplasty
- Replacement
- Shoulder
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- DePuy Orthopaedics
- Enrolment target
- 168
- Started
- 4 March 2025
- Main results due
- 10 November 2027
- Study sites
- 15
- Registry updated
- 25 September 2026
Can you take part?
- Aged 22 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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 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: 1. 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)
What this study is about
In the sponsor’s own words, from the registry.
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Study sites(15)
Orthopedic Center of Palm Beach County
Atlantis, Florida, United States
Recruiting
Boston Bone & Joint Institute BBJI Formerly BSSC
Waltham, Massachusetts, United States
Recruiting
Trinity Health Grand Rapids
Grand Rapids, Michigan, United States
Recruiting
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri, United States
Recruiting
OrthoCarolina Research Institute Charlotte
Charlotte, North Carolina, United States
Recruiting
Duke Orthopaedics of Raleigh
Raleigh, North Carolina, United States
Recruiting
Crystal Clinic Orthopaedic Center
Akron, Ohio, United States
Recruiting
Lindner Research Center
Cincinnati, Ohio, United States
Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
Slocum Center for Orthopaedics and Sports Medicine
Eugene, Oregon, United States
Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Recruiting
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania, United States
Terminated
MTBJ a division of Tennessee Orthaepedic Alliance
Columbia, Tennessee, United States
Recruiting
University of Utah
Salt Lake City, Utah, United States
Recruiting
Mary Washington Orthopedics in affiliation with FOA
Fredericksburg, Virginia, United States
Recruiting
Showing 15 of 15 sites. 14 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06323980. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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