Recruiting

INHANCE

Sponsor:

DePuy Orthopaedics

Code:

NCT06323980

Conditions

Arthroplasty

Replacement

Shoulder

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Reverse Total Shoulder

Study Details

Brief summary:

2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.

Conditions

Arthroplasty

Replacement

Shoulder

Study ID

NCT06323980

Start date

Mar 4, 2025

Status verified date

Aug, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Nov 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: INHANCE Stemless Reverse

INHANCE(TM) Stemless Reverse Total Shoulder

active comparator: INHANCE Stemmed Reverse

INHANCE(TM) Stemmed Reverse Total Shoulder

Interventions

Reverse Total Shoulder

Uncemented Reverse Total Shoulder

Primary outcome measure

  • Constant Murley Score (CMS) [ Time Frame: Pre-op, 2 years ]
  • Removal of any system component [ Time Frame: 2 year ]
  • Revision of any system component [ Time Frame: 2 year ]
  • Reoperation of any system component [ Time Frame: 2 year ]
  • Supplemental Fixation of any system component [ Time Frame: 2 year ]
  • Radiolucent Lines (Humeral & Glenoid) [ Time Frame: 2 year ]
  • Migration and Tilt (Humeral & Glenoid) [ Time Frame: 2 year ]

Central Contacts and Locations

Central contacts

Locations

Orthopedic Center of Palm Beach County

Recruiting

Atlantis, Florida, United States, 33462

Boston Bone & Joint Institute BBJI Formerly BSSC

Recruiting

Waltham, Massachusetts, United States, 02451

Trinity Health Grand Rapids

Recruiting

Grand Rapids, Michigan, United States, 49503

Missouri Orthopaedic Institute (MOI)

Recruiting

Columbia, Missouri, United States, 65201

OrthoCarolina Research Institute Charlotte

Recruiting

Charlotte, North Carolina, United States, 28207

Duke Orthopaedics of Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Crystal Clinic Orthopaedic Center

Recruiting

Akron, Ohio, United States, 44333

Lindner Research Center

Recruiting

Cincinnati, Ohio, United States, 45219

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Slocum Center for Orthopaedics and Sports Medicine

Recruiting

Eugene, Oregon, United States, 97401

St. Luke's University Health Network

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Rothman Orthopaedics Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

MTBJ a division of Tennessee Orthaepedic Alliance

Recruiting

Columbia, Tennessee, United States, 38401

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Mary Washington Orthopedics in affiliation with FOA

Recruiting

Fredericksburg, Virginia, United States, 22408

More Information

Sponsor

DePuy Orthopaedics

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Reverse Shoulder
  • Stemless Shoulder
  • Total Shoulder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by DePuy Orthopaedics on 2026-08-28.