INHANCE Stemless Reverse Shoulder IDE

Launched by DEPUY ORTHOPAEDICS · Mar 15, 2024

Keywords

ClinConnect Summary

The INHANCE Stemless Reverse Shoulder trial is a study looking at a new type of shoulder replacement surgery called the stemless reverse total shoulder replacement. This procedure is designed for individuals suffering from severe shoulder pain and disability due to arthritis or other related joint issues. The trial is currently recruiting participants aged 22 and older who are in good physical condition and have a functioning deltoid muscle, which is the main muscle of the shoulder. To be eligible, participants must also be able to understand the study information and commit to follow-up appointments.

If you join this study, you’ll receive either the new stemless shoulder implant or the standard treatment, and you’ll be asked to complete some questionnaires to help researchers understand how well the surgery works for you. It’s important to note that certain conditions, such as severe infections or significant bone issues, may prevent someone from participating. Overall, this trial aims to gather valuable data that could improve treatment options for people with shoulder arthritis, and your involvement could help shape future care.

Gender

ALL

Eligibility criteria

• 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)