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New stemless shoulder implant aims to ease arthritis pain

NCT ID NCT06323980

Disease control Sponsor: DePuy Orthopaedics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study is testing a new stemless reverse total shoulder system for people with severe shoulder arthritis. About 168 participants will be randomly assigned to get the new device or a standard one. The main goal is to see if the new implant improves shoulder function and has fewer complications over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INHANCE Stemless Reverse Total Shoulder System (a medical device)
What this could lead to
If successful, this could provide a new option for shoulder replacement that may lead to better function and fewer complications.
What could go wrong
This is an early-stage device study with 168 participants. Results may not apply to all patients, and there are risks like infection, implant loosening, or need for revision surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthroplasty Replacement Shoulder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Bone & Joint Institute BBJI Formerly BSSC

    RECRUITING

    Waltham, Massachusetts, 02451, United States

  • Crystal Clinic Orthopaedic Center

    RECRUITING

    Akron, Ohio, 44333, United States

  • Duke Orthopaedics of Raleigh

    RECRUITING

    Raleigh, North Carolina, 27609, United States

  • Lindner Research Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • MTBJ a division of Tennessee Orthaepedic Alliance

    RECRUITING

    Columbia, Tennessee, 38401, United States

  • Mary Washington Orthopedics in affiliation with FOA

    RECRUITING

    Fredericksburg, Virginia, 22408, United States

  • Missouri Orthopaedic Institute (MOI)

    RECRUITING

    Columbia, Missouri, 65201, United States

  • OrthoCarolina Research Institute Charlotte

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Orthopedic Center of Palm Beach County

    RECRUITING

    Atlantis, Florida, 33462, United States

  • Rothman Orthopaedics Institute

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Slocum Center for Orthopaedics and Sports Medicine

    RECRUITING

    Eugene, Oregon, 97401, United States

  • St. Luke's University Health Network

    RECRUITING

    Bethlehem, Pennsylvania, 18015, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Trinity Health Grand Rapids

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.