INHANCE Stemless Reverse Shoulder IDE

May 7, 2026 updated by: DePuy Orthopaedics

Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Withdrawn
        • Hoag Orthopedic Institute
      • Los Angeles, California, United States, 90048
        • Not yet recruiting
        • Cedars Sinai Medical Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • Orthopedic Center of Palm Beach County
      • West Palm Beach, Florida, United States, 33401
        • Not yet recruiting
        • Hospital for Special Surgery
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • Boston Bone & Joint Institute BBJI Formerly BSSC
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • Missouri Orthopaedic Institute (MOI)
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • OrthoCarolina Research Institute Charlotte
      • Raleigh, North Carolina, United States, 27609
        • Recruiting
        • Duke Orthopaedics of Raleigh
    • Ohio
      • Akron, Ohio, United States, 44333
        • Recruiting
        • Crystal Clinic Orthopaedic Center
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Lindner Research Center
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Slocum Center for Orthopaedics and Sports Medicine
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Health Network
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Rothman Orthopaedics Institute
    • Tennessee
      • Columbia, Tennessee, United States, 38401
        • Recruiting
        • MTBJ a division of Tennessee Orthaepedic Alliance
    • Utah
      • Murray, Utah, United States, 84107
        • Withdrawn
        • TOSH- The Orthopedic Specialty Hospital
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Not yet recruiting
        • Mary Washington Orthopedics in affiliation with FOA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: INHANCE Stemless Reverse
INHANCE(TM) Stemless Reverse Total Shoulder
Device: Reverse Total Shoulder
Uncemented Reverse Total Shoulder
Active Comparator: INHANCE Stemmed Reverse
INHANCE(TM) Stemmed Reverse Total Shoulder
Device: Reverse Total Shoulder
Uncemented Reverse Total Shoulder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Constant Murley Score (CMS)
Time Frame: Pre-op, 2 years
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
Time Frame: 2 year
No removal of any system component
2 year
Revision of any system component
Time Frame: 2 year
No revision of any system component
2 year
Reoperation of any system component
Time Frame: 2 year
No reoperation of any system component
2 year
Supplemental Fixation of any system component
Time Frame: 2 year
No supplemental fixation of any system component
2 year
Radiolucent Lines (Humeral & Glenoid)
Time Frame: 2 year
No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
2 year
Migration and Tilt (Humeral & Glenoid)
Time Frame: 2 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Constant Murley Score (CMS)
Time Frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Adjusted Constant-Murley Score at baseline and 3- and 6-months and 1- and 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, 3-month, 6-month, 1 year, 2 year
EQ-5D-5L and EQ-VAS
Time Frame: Pre-op, 3-month, 6-month, 1 year, 2 year
EQ-5D-5L Scores by dimension and EQ-VAS, at baseline and 3- and 6-months and 1- and 2-years post-operative. The value score generally ranges from less than 0 to 1, with higher scores indicating higher health utility. The EQ VAS records the subject's self-rated health from 0 (worst) to 100 (best).
Pre-op, 3-month, 6-month, 1 year, 2 year
Simple Shoulder Test
Time Frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Simple Shoulder Test (SST) Scores at baseline and 3- and 6-months and 1- and 2-years post-operative. Scores range from 0 (worst) to 12 (best).
Pre-op, 3-month, 6-month, 1 year, 2 year
Single Assessment Numeric Evaluation (SANE) Score
Time Frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Single Assessment Numeric Evaluation (SANE) Scores at baseline and 3- and 6-months and 1- and 2-years post-operative. The scale is 0 to 100 with 100 being "normal".
Pre-op, 3-month, 6-month, 1 year, 2 year
Survivorship
Time Frame: 2 year
Overall survivorship of the INHANCE Shoulder System at 2 years post-operative, where the system is deemed to be surviving if no components (humeral stem or stemless component, glenosphere, baseplate, liner, etc.) have been removed for any reason, will be presented using the Kaplan-Meier method.
2 year
Complications
Time Frame: 2 year
The type and frequency of all reportable adverse events (AEs) and device deficiencies in this study will be summarized, with distinction of serious AEs, device and procedure related AEs
2 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Constant Murley Score (CMS)
Time Frame: Pre-op, 3-month, 6-month, 1 year
Change from baseline adjusted Constant-Murley Score at 3- and 6-months and 1- year 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, 3-month, 6-month, 1 year
EQ-5D-5L and EQ-VAS
Time Frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Change from baseline EQ-5D-5L Value Score and EQ-VAS, at 3- and 6-months and 1- and 2-years post-operative. The value score generally ranges from less than 0 to 1, with higher scores indicating higher health utility. The EQ VAS records the subject's self-rated health from 0 (worst) to 100 (best).
Pre-op, 3-month, 6-month, 1 year, 2 year
Simple Shoulder Test
Time Frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Change from baseline SST Scores at 3- and 6-months and 1- and 2-years post-operative. Scores range from 0 (worst) to 12 (best).
Pre-op, 3-month, 6-month, 1 year, 2 year
Single Assessment Numeric Evaluation (SANE) Score
Time Frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Change from baseline SANE Scores at 3- and 6-months and 1- and 2-years post-operative. The scale is 0 to 100 with 100 being "normal".
Pre-op, 3-month, 6-month, 1 year, 2 year
Range of Motion
Time Frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Change from baseline range of motion at 3- and 6-months and 1- and 2-years post-operative
Pre-op, 3-month, 6-month, 1 year, 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DePuy Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DSM202108 (Other Identifier: DePuy Orthopaedics)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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