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NCT06323980From ClinicalTrials.govRecruiting

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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INHANCE Stemless Reverse Shoulder IDE | Trialion