Xavier Griffin, Consultant Trauma Surgeon, Oxford University Hospitals Foundation Trust and Chief Investigator on the trial says: "Fractures of the hip are the most devastating of the musculoskeletal fragility injuries that we see in orthopaedic trauma practice in the UK. They alone make up 1.4% of health and social care costs and herald a step change in patients mobility and independence.
Interventions which can help us better treat these injuries are crucial to improving the health of our patients. We are excited about our new collaboration with X-Bolt Orthopaedics which will allow us to investigate this implant for fixation of hip fractures which may yield better outcomes for these patients."
Fractures of the hip are the most devastating of the musculoskeletal fragility injuries that we see in orthopaedic trauma practice in the UK - Xavier Griffin, Consultant Trauma Surgeon and Chief Investigator
Hip fractures account for an estimated £1.1 billion in hospital costs annually, with failed hip fracture fixations and re-operations accounting for approximately £30m; the impact on the patients and loss of independence are immeasurable.
The 1000 patient, multicentre, randomised, controlled trial World Hip Trauma Evaluation Four (WHiTE Four) will compare two different treatments for extracapsular hip fractures - sliding hip screw fixation (SHS) and X-Bolt Dynamic Hip Plating system - following a successful smaller clinical trial that showed a zero re-operation risk for the X-Bolt System.
SHS is well established in the treatment of extracapsular fractures. However, in some hip fractures there is deficient bone to share load with the fixation device leading to failure of the fixation, often leading to more surgery and poor outcomes.
The new X-Bolt Dynamic Hip plating system builds on the successful design features of the SHS but differs in the nature of the fixation in the head. The system was designed to significantly improve the effectiveness of current surgical treatment and reduce the requirement for very costly and often devastating repeat surgery.
Both operations carry substantial and similar general risks due to the nature of the surgery and the typical frailty of the patient population. Treatment of this type of fracture remains controversial but the potential advantages of improved fixation in the femoral head may reduce failure rates with this novel device compared to the current gold standard.