INFORM - Surgery after Hip Infection Project
Research type
Research Study
Full title
A multicentred randomised trial to compare 1-stage with 2-stage revision surgery for prosthetic hip joint infection
IRAS ID
164941
Contact name
Ashley Blom
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
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 3-6 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 project 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 PJI.
To do this, 148 patients requiring revision surgery for hip PJI will be recruited into a randomised trial, from six orthopaedic centres in England and Wales. Participants will be randomised to receive either 1-stage or 2-stage revision surgery and then followed up for a total of 18 months. Participants will complete questionnaires every 3 months, to assess their hip pain and function, quality of life and any costs incurred during their treatment. Participants will attend two appointments with a research nurse to complete questionnaires and a walk test. Also a small number of participants and surgeons will be interviewed about their experiences of treatment and participation in the trial.
Participants who decline the randomised trial will be asked to join a monitoring group. This group will undergo treatment-as-usual, and then complete questionnaires at home. The monitoring group will provide important information on the wider population of patients with hip PJI, including patient reported outcomes, control of infection and adverse events.REC name
South West - Frenchay Research Ethics Committee
REC reference
14/SW/1166
Date of REC Opinion
18 Dec 2014
REC opinion
Favourable Opinion