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Evaluation of a new stemless reverse shoulder replacement device

Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System

Not applicable Interventional DePuy Orthopaedics · NCT06323980

This study is testing a new shoulder replacement device to see if it works well and is safe for people with severe arthritis who need this type of surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment168 (estimated)
Ages22 Years and up
SexAll
SponsorDePuy Orthopaedics Industry-sponsored
Drugs / interventionschemotherapy
Locations19 sites (Irvine, California and 18 other locations)
Trial IDNCT06323980 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, controlled, multi-center, prospective study assessing the effectiveness and safety of the INHANCE Stemless Reverse Cementless Total Shoulder implant. Participants will be evaluated for changes in shoulder function and safety outcomes over a two-year period following surgery. The study aims to demonstrate non-inferiority in effectiveness while ensuring that safety endpoints are met, including the absence of significant complications or device migration. The trial will involve patients who require a reverse total shoulder replacement due to severe arthritis.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 22 and older with severe shoulder arthritis who are anatomically suited for the implant and have a functional deltoid muscle.

Not a fit: Patients with a BMI over 40 kg/m2 or those with active, uncontrolled local infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a safer and more effective option for shoulder replacement surgery.

How similar studies have performed: Other studies on reverse shoulder arthroplasty have shown promising results, suggesting that this approach may be effective, though the specific stemless design is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

Irvine, California and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ArthroplastyReplacementShoulderReverse ShoulderStemless ShoulderTotal Shoulder
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.