Long-Term Safety and Performance Study of Equinoxe Proximal Humerus Fracture Plates A Multi-Center Observational Follow-Up Over 10 Years Post-Surgery

What this Trial Is About

Researchers are collecting and evaluating long-term clinical outcomes to understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This observational study follows patients who have received or will receive this specific fracture plate for proximal humeral fractures, fracture dislocations, or non-union fractures. The study is sponsored by Exactech and tracks patients up to 10 years after their surgery. Participants in this study have either undergone or are scheduled for primary surgery using the Equinoxe Proximal Humerus Fracture Plate. The study involves no experimental treatments but focuses on monitoring the outcomes of this surgical implant in real-world settings. Patients agree to attend pre- and postoperative visits and be followed for up to 10 years to provide data on their recovery and implant performance. During the study, participants will be regularly assessed using several clinical scoring tools including the Smart Score, Sane Score, ASES, and Quick DASH, with evaluations approximately once per year until study completion. These assessments help measure shoulder function and patient-reported outcomes. The study also monitors safety and implant performance long term, with data collected over a period that can extend to a decade following surgery.

Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up