Evidence map›Paper›PMID 26883420›Full record

Trial reportTrials2016

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, Michael R Whitehouse, Andrew D Beswick, Tim Board, Amanda Burston, Ben Burston, Fran E Carroll, Paul Dieppe, Kirsty Garfield, Rachael Gooberman-Hill and 16 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
12.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 74 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Observational
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Periprosthetic Joint Infection: Current Clinical Challenges.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  12. Executive Summary: Periprosthetic Joint Infection-Current Clinical Challenges.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 9 institutions in 1 country.

Simon StrangeMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. simon.strange@bristol.ac.co.uk.
Michael R WhitehouseMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. Michael.Whitehouse@bristol.ac.uk.
Andrew D BeswickMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. Andrew.Beswick@bristol.ac.uk.
Tim BoardWrightington Hospital, Wigan and Leigh NHS Foundation Trust, Hall Lane, Appley Bridge, Wrightington, Lancashire, WN6 9EP, UK. tim@timboard.co.uk.
Amanda BurstonMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. Amanda.Burston@bristol.ac.uk.
Ben BurstonThe Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation, Oswestry, Shropshire, SY10 7AG, UK. ben.burston@rjah.nhs.uk.
Fran E CarrollSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. fcarroll@rcog.org.uk.
Paul DieppeUniversity of Exeter, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK. p.dieppe@exeter.ac.uk.
Kirsty GarfieldSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Kirsty.Garfield@bristol.ac.uk.
Rachael Gooberman-HillMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. R.Gooberman-Hill@bristol.ac.uk.
Stephen JonesCardiff and Vale University Health Board, University Hospital Llandough, Penlan Road, Llandough, CF64 2XX, UK. sajones@doctors.org.uk.
Setor KunutsorMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. setor.kunutsor@bristol.ac.uk.
Athene LaneSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Athene.Lane@bristol.ac.uk.
Erik LenguerrandMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. Erik.Lenguerrand@bristol.ac.uk.
Alasdair MacGowanNorth Bristol NHS Trust, Brunel Building, Southmead Hospital, Westbury-on-Trym, Bristol, BS10 5NB, ᅟ. Alasdair.Macgowan@nbt.nhs.uk.
Andrew MooreMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. a.j.moore@bristol.ac.uk.
Sian NobleSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. S.M.Noble@bristol.ac.uk.
Joanne SimonSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Joanne.Simon@bristol.ac.uk.
Ian StockleySheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital, Herries Road, Sheffield, S5 7AU, UK. Ian.Stockley@sth.nhs.uk.
Adrian H TaylorOxford University Hospitals NHS Foundation Trust, Nuffield Orthopaedic Centre, Windmill Road, Headington, Oxford, OX3 7HE, UK. ataylor@doctors.org.uk.
Andrew TomsRoyal Devon and Exeter NHS Foundation Trust, Barrack Rd, Exeter, Devon, EX2 5DW, UK. andrewtoms@nhs.net.
Jason WebbNorth Bristol NHS Trust, Brunel Building, Southmead Hospital, Westbury-on-Trym, Bristol, BS10 5NB, ᅟ. Jason.Webb@nbt.nhs.uk.
John-Paul WhittakerThe Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation, Oswestry, Shropshire, SY10 7AG, UK. jp.whittaker@rjah.nhs.uk.
Matthew WilsonRoyal Devon and Exeter NHS Foundation Trust, Barrack Rd, Exeter, Devon, EX2 5DW, UK. matthewwilson@nhs.net.
Vikki WyldeMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. V.Wylde@bristol.ac.uk.
Ashley W BlomMusculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK. Ashley.Blom@bristol.ac.uk.
University of Bristol · GBSouthmead Hospital · GBRobert Jones and Agnes Hunt Orthopaedic Hospital · GBRoyal Devon & Exeter NHS Foundation Trust · GBSheffield Teaching Hospitals NHS Foundation Trust · GBUniversity Hospital Llandough · GBUniversity of Exeter · GBUniversity of Oxford · GBWrightington, Wigan and Leigh NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. DISCUSSION: INFORM 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.

Indexed as

Clinical ProtocolsArthroplasty, Replacement, HipCost-Benefit AnalysisHip JointHumansInfectionsJoint DiseasesOutcome Assessment, Health CarePostoperative ComplicationsQualitative ResearchQuality of Life

Identifiers

PMID26883420
PMCPMC4756538
OpenAlexW2276391253

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.