Study of Safety and Performance of the Zimmer Nexel Total Elbow in Primary and Revision Elbow Replacement

What this Trial Is About

Researchers are evaluating the safety and performance of the Zimmer Nexel Total Elbow device when used for primary or revision total elbow replacement. This study aims to confirm how well the device works and its safety by analyzing standard scoring systems, X-rays, and records of any adverse events. The study includes patients with various elbow conditions such as joint destruction, arthritis, instability, and fractures who require total elbow arthroplasty. Participants receive the Nexel Total Elbow device either as part of a primary or revision surgery. The study includes both retrospective patients who already had the device implanted and prospective patients who will receive it during the trial. The devices performance is assessed by measuring pain, function, implant survival, patient health status, and radiographic success over time. During the study, participants undergo scheduled follow-up evaluations to monitor outcomes and safety. Researchers collect information on device survivorship over a 10-year period using clinical assessments, imaging, and adverse event reports. The study involves non-randomized single-group participation without masking, with ongoing monitoring until study completion in 2036.

Clinical Outcomes Study of the Nexel Total Elbow