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

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. Plain Language Summary Surgical treatment to realign the knee, called a high tibial osteotomy, is effective at relieving symptoms of knee osteoarthritis but the operation is difficult. A new personalised treatment with simpler surgery has been designed. The aim of this study was to investigate the safety of the new personalised treatment compared to the standard treatment. For the first time, a detailed computer simulation clinical trial was performed, using imaging data from 28 real patients. The computer simulation compared the risk of the implant failure between the personalised and standard treatments. The personalised treatment did not have a higher risk of implant failure than standard treatment. This supports furth