Evaluating the NextAR Navigation System for Personalized Soft Tissue Balance in Total Knee Replacement Surgery to Improve Outcomes and Knee Movement

What this Trial Is About

Researchers are evaluating the NextAR navigation systems clinical utility in patients undergoing total knee arthroplasty for end-stage osteoarthritis. This prospective, randomized, single-blinded study aims to determine if personalized soft tissue balance data provided by the NextAR system can help prosthesis implants better resemble native knee alignment and improve patient outcomes and knee motion. Participants will undergo knee replacement surgery with either conventional instrumentation or the NextAR guidance system using the GMK Sphere implant. Clinical evaluations, including CT scans and X-rays, will be performed at various points before and after surgery. Outcomes assessed include soft tissue balance, knee kinematics via 3D gait analysis, and patient-reported measures such as the Forgotten Joint Score, Oxford Knee Score, International Knee Documentation Committee score, and quality of life questionnaires. Participants will be evaluated preoperatively and postoperatively at 6 weeks, 6 months, 1 year, and 2 years. Assessments include clinical questionnaires, imaging studies, and gait analysis to measure knee function and alignment. The primary outcome focuses on changes in the Forgotten Joint Score over time. The study duration spans up to two years following surgery with multiple follow-up visits to monitor clinical progress and knee performance.

Clinical Utility and Gait Analysis of NextAR System AUS