INHANCE Stemless Reverse Shoulder IDE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorDePuy Orthopaedics
About this trial
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Reverse Total Shoulder
Treatment groups
168 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov