Post-Market Safety and Effectiveness Study of the MAXX Orthopedics Freedom Total Knee System for Adults Needing Primary Knee Replacement

What this Trial Is About

This research aims to monitor the safety and effectiveness of the MAXX Orthopedics Freedom Total Knee System after it is on the market. It focuses on adult patients undergoing primary total knee arthroplasty TKA to meet regulatory requirements for ongoing product surveillance. The study includes up to 600 patients from about twenty registry sites, targeting an equal distribution of device types and aiming to enroll patients over approximately 10 months per site. Participants will receive the Freedom Total Knee System as part of their primary TKA procedure. The study tracks patients who have failed non-operative treatments and are scheduled for unilateral or bilateral primary TKA. The registry is observational, meaning the device is used as part of normal care, and participants are monitored over time. Recruitment includes up to 200 patients per device constraint level, and the study spans several years with data collection planned up to 24 months post-surgery. During the study, patients will complete various assessments including the Knee Society Scale, KOOS-JR, PROMIS Global-10, Visual Analog Scale, and Forgotten Joint Score at multiple timepoints from 3-6 weeks up to 24 months after surgery. Researchers will assess device survivorship over 2 years and monitor patient outcomes through questionnaires and clinical evaluations. The overall participation duration can extend up to several years, allowing for long-term safety and effectiveness data collection.

Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System