Observational Study on Safety and Performance of ORIGINae CR Devices for Total Knee Replacement in Adults

What this Trial Is About

Researchers are evaluating the safety and performance of the ORIGIN4 CR cruciate retaining devices used in total knee replacement surgery. This observational study aims to measure the safety by tracking the proportion of patients needing revision surgery one year after the procedure and to assess performance using the Knee Society Score KSS both for the knee and function at one year. The hypothesis is that patients will notice a significant natural feel improvement in the prosthesis within the first year, with slight further gains at two years, along with better overall satisfaction. The study will include 199 patients who will receive treatment with the ORIGIN4 CR devices and associated instruments. Patients will be enrolled over an 18-month period and followed for 24 months. This single-arm study does not include a comparison group and will monitor patients up to two years after their surgery to assess outcomes. Participants will be asked to attend follow-up visits at one and two years after their surgery. During these visits, researchers will evaluate safety through revision rates and assess performance using the Knee Society Score and Function Score, patient satisfaction surveys, and the Forgotten Joint Score questionnaire. The study focuses on understanding quality of life and prosthesis function after total knee replacement with the ORIGIN4 CR device.

A Post-market Observational ORIGIN® CR Clinical Study