INHANCE Stemless Reverse Shoulder IDE

Last updated: April 25, 2025
Sponsor: DePuy Orthopaedics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedics

Treatment

Reverse Total Shoulder

Clinical Study ID

NCT06323980
DSM202108
DSM202108
  • Ages > 22
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Individuals requiring reverse total shoulder replacement for a severely painful,disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis androtator cuff arthropathy).

  2. Individuals who are anatomically and structurally suited to receive the implants andhave a functional deltoid muscle.

  3. Individuals who are able to read and comprehend the informed patient consentdocument and are willing and able to provide informed patient consent forparticipation in the study and have authorized the transfer of their information toDePuy Synthes.

  4. Individuals who are willing and able to return for follow-up as specified by thestudy 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 OutcomeMeasure questionnaires (PROMs) as specified by the study protocol.

Exclusion

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 medicalassessment, bone stock in the proximal humerus or glenoid fossa is determined to beinadequate for supporting the INHANCE humeral stemless components (NOTE: exclusionapplies to both arms of the study, i.e., bone stock to be evaluated independent ofrandomized treatment assignment).

  5. Intraoperatively and per treating physician's assessment of bone quality, bone isdetermined to be too soft or porous to support the implant or that is too hard orbrittle to allow for proper bone preparation and fixation, i.e. osteoporosis orsclerotic bone, or tumor(s) of the supporting bone structure, where there could beconsiderable migration of the prosthesis and/or a chance of fracture of the humerusor glenoid.

  6. Fractures of the proximal humerus that could compromise the fixation of the INHANCEreverse humeral stemless components.

  7. Patients who have undergone previous treatment on the study shoulder that maycompromise 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 Investigatorconsiders could affect bone quality, such as chemotherapy or high dosecorticosteroids.

  10. Individuals who are bedridden per the Investigator's determination.

  11. Individuals that have participated in a clinical investigation with aninvestigational product (drug or device) in the last three months.

  12. Individuals currently involved in any personal injury litigation, medical-legal orworker's compensation claims.

  13. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers orhave psychological disorders that could affect their ability to complete patientreported questionnaires or be compliant with follow-up requirements.

  14. Patients with a known medical condition that the Investigator believes would impactthe 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 shoulderoperation within the last 6 months

  19. Otherwise determined by the investigator to be medically unsuitable forparticipation 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

Total Participants: 168
Treatment Group(s): 1
Primary Treatment: Reverse Total Shoulder
Phase:
Study Start date:
March 04, 2025
Estimated Completion Date:
September 29, 2028

Study Description

There is one primary effectiveness endpoint and there are three primary safety endpoints:

  1. Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative

  2. Primary safety endpoint(s):

    1. No revision, removal, reoperation, supplemental fixation, or other intervention for any system component

    2. No humeral or glenoid radiolucent line >2 mm is present in 50% or more zones at 2 years

    3. No conclusive evidence of migration and tilt (>5mm migration and >10° tilt) of the humeral or glenoid component at 2 years

The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant difference is seen on any of the 3 primary safety endpoints.

Connect with a study center

  • Hoag Orthopedic Institute

    Irvine, California 92618
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Orthopedic Center of Palm Beach County

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Atlantis Orthopaedics

    Lake Worth, Florida 33463
    United States

    Site Not Available

  • Boston Sports & Shoulder Center

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Trinity Health Grand Rapids

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Missouri Orthopaedic Institute (MOI)

    Columbia, Missouri 65201
    United States

    Site Not Available

  • OrthoCarolina Research Institute Charlotte

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Duke Orthopaedics of Raleigh

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Lindner Research Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Slocum Center for Orthopaedics and Sports Medicine

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Slocum Center for Orthpaedics and Sports Medicine

    Eugene, Oregon 97401
    United States

    Site Not Available

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Rothman Orthopaedics Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • MTBJ a division of Tennessee Orthaepedic Alliance

    Columbia, Tennessee 38401
    United States

    Site Not Available

  • TOSH- The Orthopedic Specialty Hospital

    Murray, Utah 84107
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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