Dublin med tech firm X-Bolt Orthopedics is to spend €1m on a clinical trial of its hip fracture medical device at Oxford University.
The 1,000-patient trial follows a successful clinical trial of 100 patients that showed a zero re-operation rate for the X-Bolt.
X-Bolt is designed to significantly improve the efficiency of current surgical treatment and reduce the requirement for very costly and often devastating repeat surgery.
The 1,000-patient, multicentre, randomised, control trial ‘WHITE Four’ (World Hip Trauma Evaluation Four), to be conducted by Oxford University, follows the recent successful ‘WHITE One’ clinical trial of 100 patients from the University of Warwick, which showed a zero percent re-operation rate with the X-Bolt device, where a 5-10pc re-operation rate would normally have been expected in these unstable intertrochanteric (the ridge where the hip meets the femur) hip fractures.
X-Bolt Orthopaedics was established by former orthopaedic surgeon Dr Brian Thornes in 2007 to develop a unique expanding bolt device for hip fracture fixation.
“Following on from the successful WHITE One 100-patient trial, which recorded a zero percent re-operation rate with the X-Bolt device, against a background of a typical 5-10pc re-operation rate in these unstable hip fractures, we are delighted to support Oxford University in conducting a larger, multicentre, randomised control trial of 1,000 patients, in order to prove statistical superiority,” Dr Thornes said.
“Failed hip fracture fixations and re-operations cost the NHS approximately £30m per annum, notwithstanding the impact and loss of independence for the individual patient.”
Hip fracture image via Shutterstock