ACCURACY OF AN IMAGE-FREE COMPUTER-ASSISTED NAVIGATION SYSTEM FOR TOTAL KNEE ARTHROPLASTY

Abstract

The correct positioning of implant components in total knee replacement (TKR) is important for a successful long-term outcome. In order to address the problems inherent with conventional alignment methods, several computer-assisted navigation systems (CAS) have been developed. Despite numerous reports of clinical outcomes and system reliability, there is a lack of studies independently evaluating the precision and accuracy of such systems. We report on the design and development of a method and device to evaluate the accuracy of such a computer-assisted navigation system in two situations; 1) Normal or near-normal lower limb mechanical axis, and 2)Simulated femoral and/or tibial extra-articular deformity in either varus/valgus (x), internal/external rotation (y) or flexion/extension (z) planes.

The system assessed was the Ci Knee-CAS navigation system (BrainLab/De Puy). This image-free system requires the registration of specific anatomical points to identify the mechanical axis of the lower limb and therefore provide information on resection level and alignment. In order to precisely measure and accurately reproduce these points we constructed a phantom device along anatomical guidelines, with lockable joints located at the mid-shaft of both femur and tibia. We then identified geometric CAS data; 1) Tibial resection height, and 2) Tibial resection plane, and using specially written software compared this against validated co-ordinate measurements independently obtained by a FaroArm co-ordinate measurement system (FARO Technologies, USA). This enabled data from the navigation system to be directly compared against highly accurate reference measurements.

Accuracy of the system was then assessed with both normal mechanical alignment of the lower limbs and simulated extra-articular deformity.