Comparing NAVIO System and Conventional Guides for Total Knee Replacement Surgery in Adults

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and costs of the NAVIO system compared to the traditional intramedullary alignment guide for total knee replacement surgery. The study aims to see if using NAVIO in total knee arthroplasty TKA is at least as efficient and safe as the conventional method. This clinical trial is a prospective, randomized, controlled, and single-blind study conducted by Sint-Trudo Hospital. Participants will undergo one of two procedures either a conventional total knee arthroplasty using the standard intramedullary alignment guide or a NAVIO-assisted total knee arthroplasty. The first 52 participants will receive CT scans of the hip, knee, and ankle before and after surgery to assess alignment accuracy. The study includes multiple follow-ups at various time points up to 10 years post-surgery to monitor outcomes. During the study, participants will be assessed through CT scans, long-leg X-rays, and various clinical scoring systems such as the Visual Analogue Scale, American Knee Society Score, Oxford Knee Score, Lower Extremities Activity Scale, and WOMAC index. Researchers will track surgery time, blood loss, hospital stay length, and complications like infections or loosening. The total participation duration may extend up to 10 years for long-term observation of clinical outcomes and safety.

Efficacy and Safety of NAVIO