Comparing Ligament Balancing in Total Knee Replacement Using a Tensioner Device Versus Standard Surgery for Patients Aged 50 to 85

What this Trial Is About

Researchers are comparing two surgical techniques for ligament balancing in patients receiving primary posterior-stabilized total knee arthroplasty TKA using the same prosthetic model. The study aims to evaluate post-operative joint laxity using stress radiographs and clinical scores in two patient groups, one treated with the standard technique and the other with the intraoperative use of a tensioner. This comparison is conducted across two specialized centers to assess differences in outcomes. The study involves two groups one undergoing standard TKA implantation with ligament balancing performed without a tensioner, and the other using the TEMIS DePuy tensioner to assist with balancing following the gap-balancing technique. Both groups receive the same cemented Attune PS mobile plate prosthesis model. The trial is randomized and does not involve blinding. Participants will have radiographic images taken at baseline, and again at 3, 6, and 12 months after surgery to measure post-operative laxity. Additional assessments include measuring the Hip-Knee-Ankle angle and using a visual analogue scale at the same time points. Patients must attend all scheduled follow-up visits for these evaluations. The total participation duration spans at least 12 months after surgery, allowing researchers to monitor recovery and knee function over time.

Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses