Evaluation of Safety and Long-Term Outcomes of the Triathlon Hinge Knee System in Primary and Revision Knee Surgeries

What this Trial Is About

Researchers are evaluating the clinical outcomes of patients undergoing primary or revision knee surgery using the Triathlon Hinge Knee System. This post-market, open-label study includes both prospectively and retrospectively enrolled patients who meet the eligibility criteria. The study aims to assess mid- and long-term survivorship of the device and identify key factors contributing to its success or failure. Survivorship is defined as the absence of aseptic revision to the implanted device. Participants receive the Triathlon Hinge Knee System components during their knee arthroplasty procedures. The system includes various femoral components, revision baseplates, tibial augments, inserts, bumpers, axles, bushings, tibial sleeves, and bearing components. The device is intended for use in revision, difficult primary, and limb salvage surgeries. The study evaluates different device configurations, including Modular Rotating Hinge and Global Modular Replacement System components. Throughout the study, data will be collected on patient demographics, surgical details, early postoperative status, and functional and clinical outcomes. Survivorship will be monitored at 1, 2, 6, and 10 years after surgery. Participants will undergo protocol-mandated clinical evaluations to assess safety and performance. The study is conducted by The Cleveland Clinic and aims to develop predictive models for successful implant fixation.

Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System