World’s first in silico clinical trial of an orthopaedic device & RCT of 3D printed personalised HTO device
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, this device is called TOKA. 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 (TOKA) and standard treatments. The personalised treatment did not have a higher risk of implant failure than standard treatment. This supports further clinical studies looking at the benefits of personalised over standard realignment surgery. The personalised treatment has the potential to allow much more widespread use of realignment surgery to treat early knee osteoarthritis.
Our SME partner is 3D Metal Printing Ltd (https://3dmetalprinting.co.uk/), who make the TOKA device.
We have fully recruited for a clinical trial at the Rizzoli Institute in Bologna, 25 patients have been successfully treated with the TOKA device (ClinicalTrials.gov NCT04574570). We are now running a randomised control trial in the UK, PASHiOn trial (ClinicalTrials.gov NCT04666571) funded by Versus Arthritis, with clinical centres in Bath, Bristol, Cardiff and Exeter. This trial has received all approvals and is now open for recruitment.