Study of a New Device for Systematic Ligament Balancing in Total Knee Replacement Surgery

What this Trial Is About

Researchers are evaluating a new approach to ligament balancing in patients undergoing total knee arthroplasty TKA who have varus deformity, a common knee issue involving shortening of the medial collateral ligament MCL. The study aims to determine if a novel instrument can provide a more systematic, objective, and repeatable method for lengthening the MCL during surgery, compared to traditional techniques that rely heavily on surgeon experience and feel. This non-randomized interventional pilot study focuses on feasibility and accuracy of the instrument in ligament balancing during knee replacement surgery. Participants who require ligament balancing during TKA will have the procedure performed using the novel instrument, which guides puncturing of the MCL in a precise grid pattern to achieve controlled ligament lengthening. The achieved ligament balance is evaluated using computer navigation and ligament tension measurement tools. The study involves a single group receiving this intervention at two hospital sites using either computer navigation or conventional instruments to assess ligament balancing. During the study, participants will be followed up as per standard protocol for total knee arthroplasty patients. Researchers will collect data on ligament lengthening, demographic factors such as age, sex, height, weight, and comorbidities, as well as patient-reported outcomes including quality of life and knee function questionnaires over a one-year period. The primary outcomes focus on feasibility of the new method and measured ligament lengthening, with safety and functional results monitored throughout the follow-up.

Ligament Balancing in Total Knee Arthroplasty