One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

Simon Strange,Joanne Simon,Vikki Wylde,Andrew Moore,Rachael Gooberman-Hill,Andrew Toms,Kirsty Garfield,Erik Lenguerrand,Alasdair Macgowan,Amanda Burston,Jason Webb,Tim Board,Sian Noble,John-Paul Whittaker,Ben Burston,Matthew Wilson,Paul Dieppe,Adrian Taylor ,Fran Carroll ,Stephen A Jones ,Setor K Kunutsor ,Michael R Whitehouse ,I Stockley ,Andrew D Beswick ,J Athene Lane ,Ashley W Blom

doi:10.1186/s13063-016-1213-8

Abstract

BackgroundPeriprosthetic joint infection (PJI) affects approximately 1 % of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision 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 practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient’s perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery.Methods/DesignINFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months.The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients’ and surgeons’ experiences, including their views about trial participation and randomisation.DiscussionINFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function and wellbeing in the long term. Patients state that these outcomes are more important than those that are clinically derived (such as re-infection) and have been commonly used in previous non-randomised studies.Results from the INFORM trial will also benefit 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.Trial registrationCurrent controlled trials ISRCTN10956306 (registered on 29 January 2015); UKCRN ID 18159.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1213-8) contains supplementary material, which is available to authorized users.

Highlights

Periprosthetic joint infection (PJI) affects approximately 1 % of patients following total hip replacement (THR) and often results in severe physical and emotional suffering
To compare outcomes of one-stage and two-stage revision of infected hip replacements, we systematically reviewed studies that included populations representative of patients in routine clinical practice
Participants Patients will be eligible for the study if they have a hip PJI, and are deemed suitable for either one-stage or twostage revision surgery by their treating surgeon

Summary

Introduction

Periprosthetic joint infection (PJI) affects approximately 1 % of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Revision surgery can be done as either a one-stage or two-stage operation Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient’s perspective. Periprosthetic joint infection (PJI) is an uncommon but serious complication, affecting approximately 1 % of patients who undergo primary THR and is the indication for over 1,000 revision procedures each year in the National Health Services of England and Wales (NHS) [1, 2]. PJI can result in severe pain, restricted movement, disability and death [3]

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