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Source: isrctn - Le promoteur: North Bristol NHS Trust
North Bristol NHS Trust MAJ Il y a 4 ans

INFORM - surgery for hip infection project 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 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. 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

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