Hip fracture in older people is a global problem that negatively affects patients' quality of life and places a burden on healthcare systems. In the UK there are about 70,000 hip fractures every year, and each is a potentially catastrophic event; approximately 20% of patients will die during the first year following the injury, and those who survive suffer pain and lack of mobility.
"About half of all hip fractures happen at the neck of the femur, or thighbone," said Matt Costa, Professor of Orthopaedic Trauma at NDORMS. "These are treated with a hip replacement procedure called hemiarthroplasty, in which the head of the femur is replaced with a metal implant. The most common method to fix the implant in place has been to use cement bonded to the patient's bone but this isn't without its risks during surgery. New implants have been designed without cement, so we set up the White 5 trial to compare any difference between the treatments and the effect on patient outcomes."
The challenge with fixing implants to the bone is that they can loosen if not bonded securely to the patient's thighbone, causing pain and restricting day to day activities. Bone cement provides reliable bonding to the bone but there is a small risk that a patient's blood pressure may drop as the cement is injected into the bone. The newer uncemented implants have been designed to provide better integration with the bone and are claimed to provide reliable fixation and an early return to normal activities, without the risks of bone cement.
The White 5 trial, a randomised controlled trial across multiple hospitals in the UK, recruited people over age 60 with a hip fracture requiring hemiarthroplasty. 610 patients were recruited to receive the cemented treatment, and 615 to the modern uncemented treatment. The primary outcome measure was the patient's quality of life measured at 1 month, 4 months and 12 months.
Published in The New England Journal of Medicine the study found that patients having the cemented treatment showed a statistically significant improvement in quality of life at a month and 4 months, but less difference at 12 months. Secondary fractures at the site of the implant were more common in the uncemented than cemented group. There was no difference between the two groups in terms of the number of people who died.
Matt Costa said: "Cemented implants provide modest but important improvements in quality of life compared with uncemented implants. The cemented implants also reduce costs for the NHS. Overall, we would recommend clinicians use cemented implants for patients having a hemiarthroplasty for their hip fracture."
The UK National Institute for Health Research (NIHR) funded the research supported by the Oxford Biomedical Research Centre.
Patient and Public Involvement (PPI)
The involvement of patients and public in trials to advance research and treatments can't be underestimated.
Alwin McGibbon, who became involved in PPI groups 15 years ago, saw the role as important in many ways. "Back when I joined, hospitals generally each had their own outcome measures, so it was like comparing apples and pears because they would have a different set of questions. I've been involved in White 5 on and off since it started, and part of my PPI work was to develop the outcome measures for the trial, which have been now adopted by most of the hospitals."
That was part of the motivation to be involved but her PPI work also extended to patient facing activities. "I was quite heavily involved, with other members of PPI, in putting documents together such as consent forms, which could include a lot of NHS terminology and jargon. We helped put them into clear English so a person on the street may be able to understand it, and what's actually happening to them. We also helped in creating leaflets for those involved and suggested putting it online so that people could see the difference they've made."
"It's nice to see the whole thing through from the beginning and knowing that you're making a difference for patients."