The first ever randomised trial to investigate why some patients develop infections after their hip or knee replacement surgery, and which type of surgical revision treatment is best is being run by the University of Bristol and members of the public are being asked to consider taking part.
Periprosthetic joint infection (PJI) affects approximately one per cent of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current treatment options include the removal of damaged or dead tissue, antibiotics and implant retention; revising (re-doing) the joint replacement; removal of the joint; and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well established in the NHS and appear to result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective.
The NIHR-funded INFORM (Infection – Orthopaedic Management) trial compares one-stage with two-stage revision for hip PJI and is co-ordinated by the University's Musculoskeletal Research Unit, based at Southmead Hospital. The trial's primary focus is on patient reported outcomes: pain, stiffness, function and wellbeing in the long-term.
The trial also compares the cost-effectiveness, complications and re-infection rates between these surgical interventions. Finally, an interview study explores patients’ and surgeons’ experiences, including their views about trial participation and randomisation.
The trial has recruited over 80 patients with PJI of the hip, from 14 orthopaedic hospitals in England and Wales and six hospitals in Sweden.
"Over 160,000 primary hip or knee replacements were carried out in England, Wales and Northern Ireland in 2016. About one person in 100 develops a bacterial infection at their new, artificial joint. Patients with infected joint replacements have described the experience as 'devastating' and 'associated with unbearable suffering'. If untreated, these infections can result in severe pain, persistent dislocation and death. It is important that we establish which form of treatment is best from a patient's perspective.
"Patients tell us that pain, function and long-term wellbeing are what is most important to them and that these are more important outcomes than those measured in previous non-randomised studies, such as re-infection. We hope the results of the trial will benefit patients in the future."
The findings will also help clinicians and NHS managers by enabling the comparison of these key interventions in terms of patients' complication rates, health and social resource use and their overall cost-effectiveness.
The INFORM programme is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme (RP-PG-1210-12005).
To register your interest in taking part in the INFORM trial, contact Simon Strange, INFORM Programme Manager, Musculoskeletal Research Unit, email firstname.lastname@example.org