INHANCE Stemless Reverse Shoulder IDE

Not Applicable

Recruiting

• Conditions: Shoulder; Replacement; Arthroplasty
• Interventions: Device: Reverse Total Shoulder

• Registration Number: NCT06323980
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

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:

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 Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-21
• Study Start: 2025-03-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-11-10
• Study Completion: 2028-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INHANCE Stemless Reverse	Reverse Total Shoulder	INHANCE(TM) Stemless Reverse Total Shoulder
INHANCE Stemmed Reverse	Reverse Total Shoulder	INHANCE(TM) Stemmed Reverse Total Shoulder

Primary Outcome Measures

Name	Time	Method
Removal of any system component	2 year	No removal of any system component
Radiolucent Lines (Humeral & Glenoid)	2 year	No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
Constant Murley Score (CMS)	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.
Revision of any system component	2 year	No revision of any system component
Migration and Tilt (Humeral & Glenoid)	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
Reoperation of any system component	2 year	No reoperation of any system component
Supplemental Fixation of any system component	2 year	No supplemental fixation of any system component

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L and EQ-VAS	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).
Constant Murley Score (CMS)	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.
Simple Shoulder Test	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).
Single Assessment Numeric Evaluation (SANE) Score	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".
Survivorship	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.
Complications	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

Trial Locations

Locations (16)

Lindner Research Center; 🇺🇸 Cincinnati, Ohio, United States

Hoag Orthopedic Institute; 🇺🇸 Irvine, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Orthopedic Center of Palm Beach County; 🇺🇸 Atlantis, Florida, United States

Boston Sports & Shoulder Center; 🇺🇸 Waltham, Massachusetts, United States

Trinity Health Grand Rapids; 🇺🇸 Grand Rapids, Michigan, United States

Missouri Orthopaedic Institute (MOI); 🇺🇸 Columbia, Missouri, United States

OrthoCarolina Research Institute Charlotte; 🇺🇸 Charlotte, North Carolina, United States

Duke Orthopaedics of Raleigh; 🇺🇸 Raleigh, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Slocum Center for Orthopaedics and Sports Medicine; 🇺🇸 Eugene, Oregon, United States

St. Luke's University Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States

Rothman Orthopaedics Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

MTBJ a division of Tennessee Orthaepedic Alliance; 🇺🇸 Columbia, Tennessee, United States

TOSH- The Orthopedic Specialty Hospital; 🇺🇸 Murray, Utah, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States