INHANCE Stemless Reverse Shoulder IDE

Recruiting now · Not applicable

Conditions studied: Arthroplasty, Replacement, Shoulder

In brief

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

Key facts

Study ID

NCT06323980

Run by

DePuy Orthopaedics

People needed

168

Starts

2025-03-04

Expected to finish

2028-10-30

Last updated by the study team

2026-07-31

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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)

Where it is running

• Rothman Orthopaedics Institute — Philadelphia, Pennsylvania, United States (enrolling)
• MTBJ a division of Tennessee Orthaepedic Alliance — Columbia, Tennessee, United States (enrolling)
• Orthopedic Center of Palm Beach County — Atlantis, Florida, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Boston Bone & Joint Institute BBJI Formerly BSSC — Waltham, Massachusetts, United States (enrolling)
• Trinity Health Grand Rapids — Grand Rapids, Michigan, United States (enrolling)
• Missouri Orthopaedic Institute (MOI) — Columbia, Missouri, United States (enrolling)
• OrthoCarolina Research Institute Charlotte — Charlotte, North Carolina, United States (enrolling)
• Duke Orthopaedics of Raleigh — Raleigh, North Carolina, United States (enrolling)
• Crystal Clinic Orthopaedic Center — Akron, Ohio, United States (enrolling)
• Lindner Research Center — Cincinnati, Ohio, United States (enrolling)
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Slocum Center for Orthopaedics and Sports Medicine — Eugene, Oregon, United States (enrolling)
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (enrolling)
• Mary Washington Orthopedics in affiliation with FOA — Fredericksburg, Virginia, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Hospital for Special Surgery — West Palm Beach, Florida, United States
• TOSH- The Orthopedic Specialty Hospital — Murray, Utah, United States
• Hoag Orthopedic Institute — Irvine, California, United States

Full record on ClinicalTrials.gov

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