Study to Evaluate Safety and Benefits of the Persona Revision Knee System in Adults with Knee Conditions

What this Trial Is About

Researchers are evaluating the Persona Revision Knee System in patients who have previously undergone primary or revision total knee arthroplasty TKA. This observational study aims to assess the devices performance, clinical benefits, and safety through a retrospective cohort with prospective follow-up. The study involves patients treated with this knee system at up to 20 sites, with a maximum enrollment of 380 participants. The study includes patients implanted with various configurations of the Persona Revision Knee System, including different tibial stems, tibial components, articular surfaces, and femoral components. Participants are identified retrospectively and then invited to participate in prospective data collection at 1, 2, 3, 4, 5, 7, and 10 years after surgery. The device and any compatible instruments used follow the approved instructions for use. Participants will provide data through scheduled follow-up visits over several years, with assessments including the Knee Society Clinical Rating System objective knee score at 2 years as the primary outcome. Secondary measures include adverse events, pain scores, and knee function scores. The study monitors safety and clinical outcomes over time, with a total participation duration potentially extending up to 10 years postoperatively.

Persona Revision Knee System Outcomes