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

  • Knee
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

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.

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Funding

This study was not funded.

Author information

Authors and Affiliations

Authors

Contributions

DC: study design, patient recruitment and data collection, and original draft preparation; AM: statistical analysis, figures and tables, and draft revision; RC, PF, CF: discussion and manuscript correction; PR: study design, surgical procedures, and manuscript correction.

Corresponding author

Correspondence to Davide Cucchi.

Ethics declarations

Conflict of interest

Author DC declares that he has no conflict of interest. Author AM declares that she has no conflict of interest. Author RC declares that he has no conflict of interest. Author PF declares that he has no conflict of interest. Author CF declares that she has no conflict of interest. Author PR declares personal fees from Arthrex and Depuy (Johnson & Johnson), outside the submitted work.

Ethical approval

The study protocol was approved by the Ethical Committee of ASL Milano 2, Protocol no. 2782.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Investigation performed at I.R.C.C.S. Policlinico San Donato, Piazza Malan 1, 20097 San Donato Milanese, Milan, Italy.

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Cucchi, D., Menon, A., Compagnoni, R. et al. Significant differences between manufacturer and surgeon in the accuracy of final component size prediction with CT-based patient-specific instrumentation for total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 26, 3317–3324 (2018). https://doi.org/10.1007/s00167-018-4876-8

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