Intra-operative results and radiological outcome of conventional and patient-specific surgery in total knee arthroplasty: a multicentre, randomised controlled trial.

PURPOSE: This prospective, double-blind, randomised controlled trial was designed to address the following research questions: firstly, is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA. Secondly, is there a significant difference in operation time, blood loss and length of hospital stay between the two techniques. We hypothesise that there will be fewer outliers with PSG TKA and that operation time, blood loss and length of hospital stay can be significantly reduced with PSG.

METHODS: A total of 180 patients were randomised for PSG TKA (group 1) or conventional TKA (group 2) in two centres. Patients were stratified per hospital. Alignment of the mechanical axis of the leg and flexion/extension and varus/valgus of the individual prosthesis components were measured on digital, standing, long-leg and standard lateral radiographs by two independent outcome assessors in both centres. Percentages of outliers (>3°) were determined. We compared blood loss, operation time and length of hospital stay.

RESULTS: There was no statistically significant difference in mean mechanical axis or outliers in mechanical axis between groups. No statistically significant difference was found for the alignment of the individual components in the frontal plane nor for the percentages of outliers. There was a statistically significant difference in outliers for the femoral component in the sagittal plane, with a higher percentage of outliers in the group 1 (p = 0.017). No such significant result was found for the tibial component in that plane. All interclass correlation coefficients were good. Blood loss was 100 mL less in group 1 (p < 0.001). Operation time was 5 min shorter in group 1 (p < 0.001). Length of hospital stay was identical with a mean of 3.6 days (p = 0.657).

CONCLUSIONS: The results in terms of obtaining a neutral mechanical axis and a correct position of the prosthesis components did not differ between groups. A small reduction in operation time and blood loss was found with the PSG system. Future research should especially focus on cost-effectiveness analysis and functional outcome of PSG TKA.

LEVEL OF EVIDENCE: I.