Study Comparing Navigation-Guided Knee Replacement Using Mechanical or Restricted Kinematic Alignment with Optetrak Logic CR Device

What this Trial Is About

Researchers are evaluating clinical outcomes and patient-reported measures in patients undergoing total knee arthroplasty TKA using two surgical alignment techniques restricted inverse kinematic alignment iKA and mechanical alignment MA. The study focuses on comparing these two approaches, both performed with surgical navigation assistance, to understand their impact on patient recovery and knee function. The clinical trial is a prospective, randomized study involving up to 148 knee replacement surgeries. Participants will receive the Optetrak Logic CR total knee system. They will be randomly assigned to either the MA TKA group or the restricted iKA TKA group, with a 50% chance of being in each. All surgeries will use ExactechGPS navigation assistance to guide the procedure. Both participants and study staff involved in the evaluation will be blinded to the group assignments until study completion. During the study, participants will be monitored at 3, 6, and 12 months post-surgery using several scoring systems including the Knee Society Score KSS, Forgotten Joint Score FJS, Knee Injury and Osteoarthritis Outcome Score KOOS, and Visual Analog Scales VAS for pain and patient satisfaction. Researchers will also assess knee alignment during surgery. Participants will attend pre-operative and post-operative visits to support data collection and follow-up. The entire process will adhere to strict clinical research regulations and data privacy standards.

Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment