ArthroplastyNCT06323980
INHANCE Stemless Reverse Shoulder IDE
A study testing Reverse Total Shoulder in people with Arthroplasty and Replacement, run by DePuy Orthopaedics at 15 sites in United States.
Trial summary
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder
- What is being tested?
- Reverse Total Shoulder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 15 sitesUnited States
- Study dates
- 4 Mar 2025to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- BMI > 40 kg/m2
- Individuals have active, uncontrolled local infection or systemic infection.
- Patients who have not reached skeletal maturity, regardless of age.
- 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).
- 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.
Show all 20Show fewer
- 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.
- Known polyethylene and/or metal sensitivity or allergy.
- Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months
- Otherwise determined by the investigator to be medically unsuitable for participation in this study
- 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)
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 14 recruiting
- Recruiting
Crystal Clinic Orthopaedic Center
Akron, Ohio, 44333
- Recruiting
Orthopedic Center of Palm Beach County
Atlantis, Florida, 33462
- Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
- Recruiting
OrthoCarolina Research Institute Charlotte
Charlotte, North Carolina, 28207
- Recruiting
Lindner Research Center
Cincinnati, Ohio, 45219
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri, 65201
- Recruiting
MTBJ a division of Tennessee Orthaepedic Alliance
Columbia, Tennessee, 38401
- Recruiting
Slocum Center for Orthopaedics and Sports Medicine
Eugene, Oregon, 97401
- Recruiting
Mary Washington Orthopedics in affiliation with FOA
Fredericksburg, Virginia, 22408
- Recruiting
Trinity Health Grand Rapids
Grand Rapids, Michigan, 49503
- Terminated
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania, 19107
- Recruiting
Duke Orthopaedics of Raleigh
Raleigh, North Carolina, 27609
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
- Recruiting
Boston Bone & Joint Institute BBJI Formerly BSSC
Waltham, Massachusetts, 02451
About this study
Official title: 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.
Read the detailed description
There is one primary effectiveness endpoint and there are three primary safety endpoints:
- Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative
- Primary safety endpoint(s):
- No revision, removal, reoperation, supplemental fixation, or other intervention for any system component
- No humeral or glenoid radiolucent line >2 mm is present in 50% or more zones at 2 years
- 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.
- Conditions
- Arthroplasty, Replacement, Shoulder
- Being tested
- Reverse Total Shoulder
- Keywords
- Reverse Shoulder, Stemless Shoulder, Total Shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Total ShoulderDevice
Uncemented Reverse Total Shoulder
| Study group | Role | What they receive |
|---|---|---|
| INHANCE Stemless Reverse | Experimental | INHANCE(TM) Stemless Reverse Total Shoulder Receives: Device: Reverse Total Shoulder |
| INHANCE Stemmed Reverse | Active comparator | INHANCE(TM) Stemmed Reverse Total Shoulder Receives: Device: Reverse Total Shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-op, 2 years
Removal of any system component
No removal of any system component
Measured: 2 year
Revision of any system component
No revision of any system component
Measured: 2 year
Reoperation of any system component
No reoperation of any system component
Measured: 2 year
Supplemental Fixation of any system component
No supplemental fixation of any system component
Measured: 2 year
Radiolucent Lines (Humeral & Glenoid)
No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
Measured: 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
Measured: 2 year
Secondary outcomes (6)
Constant Murley Score (CMS)
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.
Measured: Pre-op, 3-month, 6-month, 1 year, 2 year
EQ-5D-5L and EQ-VAS
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).
Measured: Pre-op, 3-month, 6-month, 1 year, 2 year
Simple Shoulder Test
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).
Measured: Pre-op, 3-month, 6-month, 1 year, 2 year
Single Assessment Numeric Evaluation (SANE) Score
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".
Measured: Pre-op, 3-month, 6-month, 1 year, 2 year
Survivorship
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.
Measured: 2 year
Complications
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
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start4 Mar 2025
- Primary completion10 Nov 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 Randomized (Stemless to Stemmed)
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323980
- Sponsor's protocol ID
- DSM202108
- Other IDs
- DSM202108
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
- ClinicalTrials.gov ID
- NCT06323980
- Acronym / sponsor ID
- DSM202108
- Conditions
- Arthroplasty, Replacement, Shoulder
- Keywords
- Reverse Shoulder, Stemless Shoulder, Total Shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Detailed description
There is one primary effectiveness endpoint and there are three primary safety endpoints:
- Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative
- Primary safety endpoint(s):
- No revision, removal, reoperation, supplemental fixation, or other intervention for any system component
- No humeral or glenoid radiolucent line >2 mm is present in 50% or more zones at 2 years
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 Randomized (Stemless to Stemmed)
| Arm | Type | Receives |
|---|---|---|
| INHANCE Stemless Reverse | Experimental | Device: Reverse Total ShoulderINHANCE(TM) Stemless Reverse Total Shoulder |
| INHANCE Stemmed Reverse | Active comparator | Device: Reverse Total ShoulderINHANCE(TM) Stemmed Reverse Total Shoulder |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- BMI > 40 kg/m2
- Individuals have active, uncontrolled local infection or systemic infection.
- Patients who have not reached skeletal maturity, regardless of age.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverse Total ShoulderUncemented Reverse Total Shoulder | Device | INHANCE Stemless Reverse, INHANCE Stemmed Reverse |
Primary outcome
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.
Removal of any system component
Time frame: 2 year
No removal of any system component
Revision of any system component
Time frame: 2 year
No revision of any system component
Reoperation of any system component
Time frame: 2 year
No reoperation of any system component
Supplemental Fixation of any system component
Time frame: 2 year
No supplemental fixation of any system component
Radiolucent Lines (Humeral & Glenoid)
Time frame: 2 year
No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
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
6 secondary outcomes
Constant Murley Score (CMS)
Time frame: 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
Simple Shoulder Test
Time frame: 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
Survivorship
Time frame: 2 year
Complications
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Total Shoulder in people with Arthroplasty and Replacement, run by DePuy Orthopaedics at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (574-404-7996, dfawley1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Murley Score (CMS) (time frame: Pre-op, 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.