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Recruiting NCT05615246

Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

Conditions: Osteoarthritis Shoulder, Rheumatoid Arthritis, Oncology

Sex: All
Ages: 21 Years – N/A
Enrollment: 100
Sponsor: Exactech

Location: United States

Summary

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.

Eligibility Criteria

Inclusion Criteria:Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)Patient is at least 21 years of agePatient is expected to survive at least 2 years beyond surgeryPatient is willing to participate by complying with pre- and postoperative visit requirementsPatient is willing and able to read and sign a study informed consent formExclusion Criteria:Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolvedInadequate or malformed bone that precludes adequate support or fixation of the prosthesisNeuromuscular disorders that do not allow control of the jointSIgnigicant injury to the brachial plexusNon-functional deltoid musclesPatient's age, weight, or activity level would cause the surgeon to expect early failure of the systemThe patient is unwilling or unable to comply with the post-operative care instructionsAlcohol, drug, or other subtance abuseAny disease state that could adversely affect the function or longevity of the implantPatient is pregnantPatient is a prisonerPatient has a physical or mental condition that would invalidate the results

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05615246). StuddyBuddy aggregates publicly available trial information.