Taking an innovative approach to clinical research in hip fracture, the World Hip Trauma Evaluation (WHiTE) Platform Trial has been launched to test multiple new treatments for patients with fractures of the hip.
Hip fractures are a major global health challenge, with 1.3 million cases per year worldwide, a figure expected to rise to over 6 million by 2050. These fractures can be devastating, with high rates of mortality, reduced quality of life and significant healthcare costs.
Hosted by the University of Oxford’s Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) and developed through the NIHR Oxford Biomedical Research Centre (BRC), the new WHiTE Platform Trial will allow researchers to simultaneously test multiple treatments for hip fractures, which is a significant shift from traditional trials that typically focus on one treatment at a time.
Juul Achten, Head of Research Development and Delivery at Oxford Trauma and Emergency Care, said: “Recent observational studies show significant variation in clinical practice, from assessment, through surgical and perioperative care, and then rehabilitation and secondary prevention of future fractures. Variation in care can lead to variation in patients’ recovery.
“This injury can have devastating effects on older adults, not just physically but also emotionally and socially and there is therefore a pressing need to extend and improve treatments and treatment pathways. The WHiTE Platform Trial offers the opportunity to test multiple interventions to improve patient outcomes, accelerate the pace of discovery and ensure patients receive the best possible care.”
The WHiTE Platform Trial was developed by a team of patient representatives from the UK Musculoskeletal Trauma Patient and Public Involvement Group, clinical experts in the care of patients with hip fracture, trial management specialists and experienced statisticians and health economists.
It provides a framework for running multiple randomised comparisons of six different interventions for hip fracture patients aged 60 and older. These comparisons cover different types of surgical interventions, ways to reduce delirium after surgery, ways to reduce the risk of pressure sores, and ways to speed up mobilisation after surgery. The interventions can be delivered at any stage along the diagnostic, treatment and rehabilitation pathway for hip fracture patients.
All eligible patients presenting to the 80 participating recruitment hospitals will be offered the opportunity to take part in the relevant randomised comparisons.
The trial will collect data on various treatments and measure common outcomes. The primary outcome measure is health-related quality-of-life (HRQoL), as reported by the patients themselves.
The trial also collects data about patients’ mobility, care needs and where they are living. Complications and use of healthcare resources are reported in the four months after the hip fracture, while longer-term outcomes will also be assessed through linkage to routine healthcare databases.
The findings from the WHiTE Platform Trial will directly inform national and international policy and practice guidelines for the management of hip fracture patients. Importantly, the research will be disseminated widely to patients, clinicians and the general public to maximise the impact.
“This is a game-changing initiative that has the potential to leverage efficiencies in the delivery of clinical care,” said Matt Costa, Professor of Orthopaedic Trauma Surgery at NDORMS and Lead for the Oxford BRC’s Musculoskeletal Theme.
“As the WHiTE Platform Trial progresses, we hope it will pave the way for innovative treatments and improved recovery processes for those affected by hip fractures, making a real difference in the lives of many older adults.”