INHANCE Stemless Reverse Shoulder IDE

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: Recruiting
• Conditions: Arthroplasty; Replacement; Shoulder
• Intervention / Treatment: Device: Reverse 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 Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 574-404-7996; Email: dfawley1@its.jnj.com

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      • Withdrawn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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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".	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.	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	2 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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".	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	Pre-op, 3-month, 6-month, 1 year, 2 year

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Reverse Shoulder; Stemless Shoulder; Total Shoulder
• Other Study ID 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