An interventional study of Reverse Total Shoulder in Arthroplasty, Replacement and Shoulder, sponsored by DePuy Orthopaedics. Active, not recruiting at 15 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by DePuy Orthopaedics (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
There is one primary effectiveness endpoint and there are three primary safety endpoints:
Primary safety endpoint(s):
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.
DePuy Orthopaedics is the lead sponsor of 45 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
First submitted after DePuy Orthopaedics became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INHANCE(TM) Stemless Reverse Total Shoulder
Device: Reverse Total Shoulder
INHANCE(TM) Stemmed Reverse Total Shoulder
Device: Reverse Total Shoulder
Uncemented Reverse Total Shoulder
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.
Time frame: Pre-op, 2 years
Removal of any system component
No removal of any system component
Time frame: 2 year
Revision of any system component
No revision of any system component
Time frame: 2 year
Reoperation of any system component
No reoperation of any system component
Time frame: 2 year
Supplemental Fixation of any system component
No supplemental fixation of any system component
Time frame: 2 year
Radiolucent Lines (Humeral & Glenoid)
No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
Time frame: 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
Time frame: 2 year
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.
Time frame: 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).
Time frame: 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).
Time frame: 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".
Time frame: 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.
Time frame: 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
Time frame: 2 year
Constant Murley Score (CMS)
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.
Time frame: Pre-op, 3-month, 6-month, 1 year
EQ-5D-5L and EQ-VAS
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).
Time frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Simple Shoulder Test
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).
Time frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Single Assessment Numeric Evaluation (SANE) Score
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".
Time frame: Pre-op, 3-month, 6-month, 1 year, 2 year
Range of Motion
Change from baseline range of motion at 3- and 6-months and 1- and 2-years post-operative
Time frame: Pre-op, 3-month, 6-month, 1 year, 2 year
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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