RANDOMIZED CONTROLLED TRIAL COMPARING FUNCTIONAL OUTCOME FOR FIXED AND MOBILE BEARING IN TOTAL KNEE ARTHROPLASTY

Abstract

The aim of this study was to determine whether there is a difference in the functional outcome between fixed and mobile bearings in total knee arthroplasty.

120 patients were randomized (computer generated) to receive either a fixed or mobile bearing P.F.C. Sigma total knee replacement. 96 patients were needed to detect a 20° difference in range of motion (ROM) with a significance level of 0.05 and a test power of 0.97. Oxford knee score (OKS) and ROM were assessed independently before and one year after surgery.

Mean ROM and Oxford knee score before and at one year after surgery for both groups are shown as preliminary results for 70 patients (follow-up expected to be completed by March 2006):

There is no statistically significant difference in the mean ROM at one year and in change in ROM between the two groups (p=0.53 and p=0.21 respectively). The findings were similar for Oxford Knee Score at one year and change in Oxford Knee Score (p=0.45 and p=0.82). There was no early aseptic loosening in either group.

The one year results suggest that there is no significant difference in functional outcome measured as ROM and Oxford Knee Score between the two types of bearing. Further follow-up will be carried out to detect any differences in the long term outcome.