RecruitingNot Applicable

INHANCE Stemless Reverse Shoulder IDE

United States168 participantsStarted 2025-03-04

Plain-language summary

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

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Constant Murley Score (CMS)

Timeframe: Pre-op, 2 years

Removal of any system component

Timeframe: 2 year

Revision of any system component

Timeframe: 2 year

Reoperation of any system component

Timeframe: 2 year

Supplemental Fixation of any system component

Timeframe: 2 year

Radiolucent Lines (Humeral & Glenoid)

Timeframe: 2 year

Migration and Tilt (Humeral & Glenoid)

Timeframe: 2 year

Trial details

NCT IDNCT06323980

SponsorDePuy Orthopaedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-10

Contact for this trial

Study Contact

574-404-7996 dfawley1@its.jnj.com

View on ClinicalTrials.gov More Arthroplasty trials

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Constant Murley Score (CMS)

Timeframe: Pre-op, 2 years

Removal of any system component

Timeframe: 2 year

Revision of any system component

Timeframe: 2 year

Reoperation of any system component

Timeframe: 2 year

Supplemental Fixation of any system component

Timeframe: 2 year

Radiolucent Lines (Humeral & Glenoid)

Timeframe: 2 year

Migration and Tilt (Humeral & Glenoid)

Timeframe: 2 year