Personalised high tibial osteotomy has mechanical safety equivalent to generic device in a case-control in silico clinical trial

Alisdair R MacLeod; Nicholas Peckham; Gil Serrancolí; Ines Rombach; Patrick Hourigan; Vipul I Mandalia; Andrew D Toms; Benjamin J Fregly; Harinderjit S Gill

doi:10.1038/s43856-021-00001-7

Personalised high tibial osteotomy has mechanical safety equivalent to generic device in a case-control in silico clinical trial

Commun Med (Lond). 2021 Jun 30:1:6. doi: 10.1038/s43856-021-00001-7. eCollection 2021.

Authors

Alisdair R MacLeod¹, Nicholas Peckham², Gil Serrancolí³, Ines Rombach², Patrick Hourigan⁴, Vipul I Mandalia⁴, Andrew D Toms⁴, Benjamin J Fregly⁵, Harinderjit S Gill^{1

6}

Affiliations

¹ Department of Mechanical Engineering, University of Bath, Bath, UK.
² Oxford Clinical Trials Research Unit, NDORMS, University of Oxford, Oxford, UK.
³ Department of Mechanical Engineering, Polytechnic University of Catalonia, Barcelona, Catalunya Spain.
⁴ Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
⁵ Department of Mechanical Engineering, Rice University, Houston, TX USA.
⁶ Centre for Therapeutic Innovation, University of Bath, Bath, UK.

Abstract

Background: Despite favourable outcomes relatively few surgeons offer high tibial osteotomy (HTO) as a treatment option for early knee osteoarthritis, mainly due to the difficulty of achieving planned correction and reported soft tissue irritation around the plate used to stablise the osteotomy. To compare the mechanical safety of a new personalised 3D printed high tibial osteotomy (HTO) device, created to overcome these issues, with an existing generic device, a case-control in silico virtual clinical trial was conducted.

Methods: Twenty-eight knee osteoarthritis patients underwent computed tomography (CT) scanning to create a virtual cohort; the cohort was duplicated to form two arms, Generic and Personalised, on which virtual HTO was performed. Finite element analysis was performed to calculate the stresses in the plates arising from simulated physiological activities at three healing stages. The odds ratio indicative of the relative risk of fatigue failure of the HTO plates between the personalised and generic arms was obtained from a multi-level logistic model.

Results: Here we show, at 12 weeks post-surgery, the odds ratio indicative of the relative risk of fatigue failure was 0.14 (95%CI 0.01 to 2.73, p = 0.20).

Conclusions: This novel (to the best of our knowledge) in silico trial, comparing the mechanical safety of a new personalised 3D printed high tibial osteotomy device with an existing generic device, shows that there is no increased risk of failure for the new personalised design compared to the existing generic commonly used device. Personalised high tibial osteotomy can overcome the main technical barriers for this type of surgery, our findings support the case for using this technology for treating early knee osteoarthritis.

Keywords: Health care; Medical research.