Plain English Summary
Background and study aims
Hip replacement surgery is common, with over 86,000 cases in England and Wales in 2012. After surgery about 1% patients develop a deep infection in their artificial hip, called a prosthetic joint infection (PJI). If left untreated PJI can result in severe pain, disability and death. When an infection is found, there are two types of surgical treatment: a 1-stage revision involves removing the joint, thoroughly cleaning the infected area and implanting a new joint immediately; a 2-stage revision involves removing the joint, and delaying re-implantation for 3 to 6 months whilst treating with antibiotics. Both treatments are widely used but we don’t know which has the best long-term outcomes for patients. The aim of this study is to find out whether there is any difference in patient-reported outcomes (pain, stiffness or physical function) after 1-stage or 2-stage revision hip surgery for PJI.
Who can participate?
Patients that have a prosthetic joint infection that needs surgery.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 have 1-stage revision surgery. Those in group 2 have 2-stage revision surgery. All participants are then followed up for the next 18 months. They are asked to complete questionnaires every 3 months, to assess their hip pain and function, quality of life and any costs incurred during their treatment. They attend two appointments with a research nurse to complete questionnaires and a walk test. A small number of participants and surgeons are also interviewed about their experiences of treatment and participation in the trial. Participants who decide against the randomised trial are asked to join a monitoring group. This group have treatment-as-usual, and then complete questionnaires at home. The monitoring group provide important information on the wider population of patients with hip PJI, including patient reported outcomes, control of infection and adverse events.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
A total of six orthopaedic centres in England and Wales (UK)
When is the study starting and how long is it expected to run for?
January 2015 to January 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Simon Strange
Mr Simon Strange
INFORM Programme Manager
Musculoskeletal Research Unit
Learning and Research
+44 (0)117 414 7867
A multicentre randomised trial to compare 1-stage with 2-stage revision surgery for prosthetic hip joint infection
The aim of this study is to determine if there is any difference in patient-reported outcomes (pain, stiffness or physical function) after 1-stage or 2-stage revision hip surgery for prosthetic joint infection (PJI).
NRES Committee South-West - Frenchay, 31/12/2014, ref: 14/SW/1166
Randomised; Interventional and Observational; Design type: Not specified, Treatment, Qualitative
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Topic: Surgery; Subtopic: Surgery; Disease: All Surgery
Revision hip surgery
1-stage or 2-stage revision for infected prosthetic hip joint; Follow Up Length: 18 month(s)
Primary outcome measures
Patient-reported hip pain, stiffness, function; Timepoint(s): WOMAC at 18 months post-randomisation
Secondary outcome measures
1. Quality of life, measured using Euroquol EQ-5D-5L and HOOS
2. All hip-related complications (including continuing and reinfection) recorded throughout study period
3. Post-op pain, measured using the Brief Pain Inventory
4. Patient-reported hip function, measured using the Oxford Hip Score
5. Objective measure of hip function, measured using the 20 metre timed walk test
6. Depression and anxiety, measured using the Hospital Anxiety and Depression Score
7. Cost-effectiveness of interventions, measured using health resource use
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Age 18 or above
2. A clinical diagnosis of prosthetic hip joint infection
3. Require revision surgery (either 1-stage or 2-stage) to treat prosthetic hip joint infection, in the opinion of the treating consultant orthopaedic surgeon
Target Gender: Male & Female ; Lower Age Limit 18 years
Target number of participants
Planned Sample Size: 228; UK Sample Size: 228; Description: RCT - 148 patients (est. 123 England and 25 Wales)Monitoring group - approx 80 participants
Participant exclusion criteria
1. Unable or unwilling to undergo either 1-stage or 2-stage revision surgery
2. Lack capacity to give written informed consent
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
North Bristol NHS Trust
Trust Headquarters Beckspool Road Frenchay
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. Protocol paper
2. Trial results paper
3. Cost-effectiveness analysis paper
4. Dissemination of Best Practice Guidance
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26883420