Significant differences between manufacturer and surgeon in the accuracy of final component size prediction with CT-based patient-specific instrumentation for total knee arthroplasty

Purpose: Patient-specific instrumentation (PSI) for total knee arthroplasty (TKA) may improve component sizing. Little has been reported about accuracy of the default plan created by the manufacturer, especially for CT-based PSI. The goal of this study was to evaluate the reliability of this plan and the impact of the surgeon’s changes on the final accuracy of the guide sizes. Methods: Forty-five patients eligible for primary TKA were prospectively enrolled. The planned implant sizes were prospectively recorded from the initial manufacturer’s proposal and from the final plan adjusted in light of the surgeon’s evaluation; these two sizes where then compared to the actually implanted sizes. Fisher’s exact test was used to test differences for categorical variables. Agreement between pre-operative plans and final implant was evaluated with the Bland–Altman method. Results: The manufacturer’s proposal differed from the final implant in 9 (20.0%) femoral and 23 (51.1%) tibial components, while the surgeon’s plan in 6 (13.3%, femoral) and 12 (26.7%, tibial). Modifications in the pre-operative plan were carried out for five (11.1%) femoral and 23 (51.1%) tibial components (p = 0.03). Appropriate modification occurred in 22 (88.0%) and 19 (76.0%) cases of femoral and tibial changes. The agreement between the manufacturer’s and the surgeon’s pre-operative plans was poor, especially with regard to tibial components. Conclusion: The surgeon’s accuracy in predicting the final component size was significantly different from that of the manufacturer and changes in the initial manufacturer’s plan were necessary to get an accurate pre-operative plan of the implant sizes. Clinical relevance: Careful evaluation of the initial manufacturer’s plan by an experienced knee surgeon is mandatory when planning TKA with CT-based PSI. Level of evidence: II.