INHANCE Stemless Reverse Shoulder IDE

NCT06323980 | Recruiting FDA Device

• 1 other identifier: DSM202108
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Arthroplasty; Replacement; Shoulder

Keywords

Reverse Shoulder; Stemless Shoulder; Total Shoulder

Outcome Measures

Primary Outcomes (7)

• Constant Murley Score (CMS)

  Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative. The CMS is a 100 point scale, the higher the score, the higher the quality of the function. ACM will be obtained by dividing the raw score by the relative score.

  Pre-op, 2 years

• Removal of any system component

  No removal of any system component

  2 year

• Revision of any system component

  No revision of any system component

  2 year

• Reoperation of any system component

  No reoperation of any system component

  2 year

• Supplemental Fixation of any system component

  No supplemental fixation of any system component

  2 year

• Radiolucent Lines (Humeral & Glenoid)

  No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones

  2 year

• Migration and Tilt (Humeral & Glenoid)

  No conclusive evidence of migration and tilt (greater than 5mm migration and greater than 10 degrees tilt) of the humeral or glenoid component

  2 year

Secondary Outcomes (6)

• Constant Murley Score (CMS)

  Pre-op, 3-month, 6-month, 1 year, 2 year

• EQ-5D-5L and EQ-VAS

  Pre-op, 3-month, 6-month, 1 year, 2 year

• Simple Shoulder Test

  Pre-op, 3-month, 6-month, 1 year, 2 year

• Single Assessment Numeric Evaluation (SANE) Score

  Pre-op, 3-month, 6-month, 1 year, 2 year

• Survivorship

  2 year

Other Outcomes (5)

• Constant Murley Score (CMS)

  Pre-op, 3-month, 6-month, 1 year

• EQ-5D-5L and EQ-VAS

  Pre-op, 3-month, 6-month, 1 year, 2 year

• Simple Shoulder Test

  Pre-op, 3-month, 6-month, 1 year, 2 year

Study Arms (2)

INHANCE Stemless Reverse

EXPERIMENTAL

INHANCE(TM) Stemless Reverse Total Shoulder

Device: Reverse Total Shoulder

INHANCE Stemmed Reverse

ACTIVE COMPARATOR

INHANCE(TM) Stemmed Reverse Total Shoulder

Device: Reverse Total Shoulder

Interventions

Reverse Total Shoulder DEVICE

Uncemented Reverse Total Shoulder

INHANCE Stemless Reverse; INHANCE Stemmed Reverse

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy).
• Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.
• 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.
• Individuals who are willing and able to return for follow-up as specified by the study protocol.
• Individuals who are a minimum age of 22 years at the time of consent.
• Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.

You may not qualify if:

• BMI \> 40 kg/m2
• Individuals have active, uncontrolled local infection or systemic infection.
• Patients who have not reached skeletal maturity, regardless of age.
• 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.
• Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.
• Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component.
• Revision of a failed hemi, total or reverse shoulder arthroplasty.
• Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids.
• Individuals who are bedridden per the Investigator's determination.
• Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
• Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• 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.
• 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).
• Patient has a medical condition with less than 2 years life expectancy.
• Patients who are known to be pregnant or breastfeeding.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (19)

Hoag Orthopedic Institute

Irvine, California, 92618, United States

WITHDRAWN

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Orthopedic Center of Palm Beach County

Atlantis, Florida, 33462, United States

RECRUITING

Hospital for Special Surgery

West Palm Beach, Florida, 33401, United States

NOT YET RECRUITING

Boston Bone & Joint Institute BBJI Formerly BSSC

Waltham, Massachusetts, 02451, United States

NOT YET RECRUITING

Trinity Health Grand Rapids

Grand Rapids, Michigan, 49503, United States

RECRUITING

Missouri Orthopaedic Institute (MOI)

Columbia, Missouri, 65201, United States

RECRUITING

OrthoCarolina Research Institute Charlotte

Charlotte, North Carolina, 28207, United States

RECRUITING

Duke Orthopaedics of Raleigh

Raleigh, North Carolina, 27609, United States

RECRUITING

Crystal Clinic Orthopaedic Center

Akron, Ohio, 44333, United States

RECRUITING

Lindner Research Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Slocum Center for Orthopaedics and Sports Medicine

Eugene, Oregon, 97401, United States

RECRUITING

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Rothman Orthopaedics Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MTBJ a division of Tennessee Orthaepedic Alliance

Columbia, Tennessee, 38401, United States

RECRUITING

TOSH- The Orthopedic Specialty Hospital

Murray, Utah, 84107, United States

WITHDRAWN

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Fredericksburg Orthopaedic Assoc

Fredericksburg, Virginia, 22401, United States

NOT YET RECRUITING

Central Study Contacts

Study Contact

CONTACT

574-404-7996; dfawley1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 Randomized (Stemless to Stemmed)

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 21, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): September 29, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (19)