RANDOMISED, CONTROLLED TRIAL OF TOTAL KNEE REPLACEMENT SURGERY USING IMAGE GUIDED NAVIGATION

Abstract

Image guided navigation systems for total knee replacement surgery (TKR) are gaining popularity in an effort to improve both alignment and functional outcome. This trial was undertaken to compare one year functional outcome and radiological alignment of TKRs inserted with and without an image guided navigation system.

Patients were randomised to undergo surgery using either an image guided navigation system or traditional instrumentation. Pre and post-operative Knee Society (KSS), WOMAC and SF-36 scores were collected. Postoperatively, limb and implant alignment & rotation were assessed using both full-length films and CT scans.

One hundred and twenty-three patients (one hundred and forty-five knees) were enrolled: eighty-one females, forty-two males, mean age sixty-seven years. Age, gender and pre-operative range of motion, KSS WOMAC and SF-36 scores did not differ between the groups. While there was no statistically significant difference in postoperative KSS, WOMAC and seven of eight SF-36 subscales, the navigated group demonstrated better post-operative SF-36 General Health Scores. Mean postoperative flexion in all patients was 115°, and did not differ between groups. Mean post-operative leg alignment demonstrated more varus in the navigated group (2.1°) versus the non-navigated group (0.9°, p=0.02), however there was a trend towards a smaller standard deviation in the navigated group. Rotational alignment of the femoral component relative to the femur, tibial component relative to the tibia, and tibial component relative to the femoral component were not statistically different between groups; however, there were larger standard deviations of these measures in the non-navigated group. Pre-operative alignment appeared to affect tibial component placement; varus knees had a mean of 3° of tibial component internal rotation while valgus knees had a mean of 12° external rotation.

Imaged guided navigation systems appear to reduce the variability in TKR component placement and limb alignment. However, this may not necessarily translate into better mean limb alignment or early functional outcome.