ACCURACY EVALUATION FOR COMPUTER-ASSISTED NAVIGATION TOOLS IN TOTAL KNEE REPLACEMENT

Abstract

Implant malposition remains one of the common causes of total knee replacement (TKR) failure and increased wear. Recent advances in computer technology have made available navigation systems for TKR and other orthopaedic procedures. The purpose of our study was:

1. to develop a method to assess the accuracy of an image-free TKR navigation system;

2. to assess its accuracy in a leg with normal or near-normal mechanical axis;

3. to assess its accuracy in a leg with abnormal mechanical axis.

The system chosen was an image-free system based on electromagnetic technology, the MedTronic AxiEM TKR navigation system. To facilitate measurements, an artificial leg (phantom) was constructed from machined Plexiglas with simulated hip and knee joints. Additional joints located at the midshaft of the tibia and femur allowed deformation in the flexion/extension (y), varus/valgus (x) and rotational (z) planes. Using a highly accurate digital calliper unit (FaroARM Technologies, USA) to precisely measure co-ordinates with pre-machined points on the phantom, a software program was developed to convert these local co-ordinates into a determination of actual leg alignment. This technique was verified using repeated measurement with variable coordinates, giving accuracy to within 0.05 of a degree.

Simulated procedures were then performed with both normal and abnormal leg mechanical axis. At specific points in the procedure, information was compared between the FaroARM digital measurements and the CAS system. Repeated serial measurements were undertaken. In the setting of normal alignment, accuracy to within one degree was demonstrated. In the setting of abnormal x, y and z plane alignment in both femur and tibia, accuracy to within two degrees was demonstrated.

Several clinical studies have been performed to assess the precision of computer navigation in TKR. This study was designed to assess the accuracy of a clinically validated navigation system. The study demonstrates the high level of in-vitro accuracy of the MedTronic AxiEM navigation system in both normal and abnormal mechanical leg alignment settings.