The first ever randomised trial to investigate why some patients develop infections after hip or knee replacement surgery, and which type of surgical revision treatment is best, has begun in the UK.
Periprosthetic joint infection affects approximately 1% of patients following total hip replacement and often results in severe physical and emotional suffering.
“Patients with infected joint replacements have described the experience as ‘devastating’”
Current treatment options include the removal of damaged or dead tissue, antibiotics and implant retention, revising the joint replacement, removal of the joint and amputation.
Revision surgery can be done as either a one-stage or two-stage operation. Both are well established and appear to result in similar re-infection rates, but little is known about the impact from the patient’s perspective.
The INFORM (Infection – Orthopaedic Management) trial is comparing one-stage with two-stage revision. Its primary focus is on patient reported outcomes – pain, stiffness, function and long-term wellbeing.
But the trial, co-ordinated by the Bristol University’s musculoskeletal research unit, is also comparing the cost-effectiveness, complications and re-infection rates between the surgical interventions.
In addition, an interview study will explore patient and surgeon experiences, including their views about trial participation and randomisation.
The trial has recruited over 80 patients, from 14 orthopaedic hospitals in England and Wales and six hospitals in Sweden.
Professor Ashley Blom, joint head of the unit, said: “Over 160,000 primary hip or knee replacements were carried out in England, Wales and Northern Ireland in 2016.
Groundbreaking trial underway for prosthetic hip joint infection
“About one person in 100 develops a bacterial infection at their new, artificial joint,” he said. “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,” he noted.
“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,” he said. “We hope the results of the trial will benefit patients in the future.”
The university added that the findings would also enable comparison of the interventions in terms of patients’ complication rates, health and social resource use and their overall cost-effectiveness.
The INFORM programme is being funded by the National Institute for Health Research.