Robotic-Assisted Knee Replacement Surgery Comparing Personalized and Mechanical Alignment Techniques for Knee Osteoarthritis

What this Trial Is About

Researchers are comparing two surgical techniques for total knee arthroplasty TKA in patients with knee osteoarthritis. The study evaluates the traditional mechanical alignment method, which aims for a neutral knee position, against a personalized approach called kinematic alignment that tries to restore the patients natural knee anatomy. This trial uses robotic-assisted surgery to improve precision and aims to determine if personalized alignment offers equal or better implant longevity and clinical outcomes. Participants will undergo knee replacement surgery using the ROSA Knee System robot and receive either mechanical alignment or personalized alignment. The tibial implant placement will be controlled within specific angles to ensure safety. This randomized, triple-blinded trial involves 152 patients and focuses on comparing the stability, position, and clinical outcomes of implants placed using these two alignment methods. During the study, participants will be assessed through clinical tests and specialized CT scans to measure implant migration and stability over two years. Researchers will also evaluate physical activity, strength, walking, stair climbing, and patient-reported outcomes at one and two years after surgery. The study includes safety monitoring for potential complications related to robotic surgery, such as fractures or infections, with follow-up lasting until 2035.

The personalKNEE Trial