Study of Safety and Performance of Zimmer Persona Personalized Knee System With Canary canturioTM Tibial Extension After Knee Replacement Surgery

What this Trial Is About

Researchers are evaluating the safety, reliability, reproducibility, and accuracy of the Canary canturioTM tibial extension in patients who have undergone total knee arthroplasty TKA due to knee osteoarthritis. This observational study compares outcomes between patients receiving the Zimmer Persona Personalized Knee System with the Canary canturioTM tibial extension and those receiving the Zimmer Persona system with a standard 14 mm 30 mm stem extension. The study aims to monitor safety risks and gait performance over five years post-TKA. Participants are divided into two groups one with the Canary canturioTM tibial extension and one with a standard stem extension. Safety endpoints include revision surgeries, loosening, fractures, and radiologic changes within five years after surgery. Secondary endpoints assess data collection on step counts and gait parameters, as well as patient-reported pain, knee function, and quality of life. A subgroup of patients will have detailed gait lab assessments at one and two years post-TKA. During the study, participants will be monitored for adverse events and their gait will be tracked using wearable technology to collect step count and walking data. Patient-reported outcomes such as pain scores and quality of life questionnaires will be completed regularly. The study lasts five years from the time of knee replacement surgery, with continuous data collection and periodic evaluations to assess the performance and safety of the knee systems.

A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension