Abstract
PURPOSE: To assess whether there is a significant difference between the alignment of the individual femoral and tibial components (in the frontal, sagittal and horizontal planes) as calculated pre-operatively (digital plan) and the actually achieved alignment in vivo obtained with the use of patient-specific positioning guides (PSPGs) for TKA. It was hypothesised that there would be no difference between post-op implant position and pre-op digital plan. METHODS: Twenty-six patients were included in this non-inferiority trial. Software permitted matching of the pre-operative MRI scan (and therefore calculated prosthesis position) to a pre-operative CT scan and then to a post-operative full-leg CT scan to determine deviations from pre-op planning in all three anatomical planes. RESULTS: For the femoral component, mean absolute deviations from planning were 1.8° (SD 1.3), 2.5° (SD 1.6) and 1.6° (SD 1.4) in the frontal, sagittal and transverse planes, respectively. For the tibial component, mean absolute deviations from planning were 1.7° (SD 1.2), 1.7° (SD 1.5) and 3.2° (SD 3.6) in the frontal, sagittal and transverse planes, respectively. Absolute mean deviation from planned mechanical axis was 1.9°. The a priori specified null hypothesis for equivalence testing: the difference from planning is >3 or <-3 was rejected for all comparisons except for the tibial transverse plane. CONCLUSION: PSPG was able to adequately reproduce the pre-op plan in all planes, except for the tibial rotation in the transverse plane. Possible explanations for outliers are discussed and highlight the importance for adequate training surgeons before they start using PSPG in their day-by-day practise. LEVEL OF EVIDENCE: Prospective cohort study, Level II.