Re-infection outcomes following one- and two-stage surgical revision of infected hip prosthesis in unselected patients: protocol for a systematic review and an individual participant data meta-analysis

Setor K. Kunutsor, Michael R. Whitehouse, Jason Webb, Andrew Toms, Ian Stockley, Adrian Taylor, Stephen Jones, Matthew Wilson, Ben Burston, Tim Board, John Paul Whittaker, Ashley W. Blom, Andrew D. Beswick

Research output: Contribution to journalArticle (Academic Journal)

5 Citations (Scopus)

Abstract

BACKGROUND: Several aggregate published reviews have compared the effectiveness of one- and two-stage surgical revision to prevent re-infection following prosthetic hip infection and have reported inconsistent results. In addition, there were several features of these previous reviews which limited the validity of the findings. In the absence of a well-designed clinical trial, we propose the Global Infection Orthopaedic Management (INFORM) collaboration, a worldwide collaborative systematic review and meta-analysis of individual participant data (IPD) to address the existing uncertainties.

METHODS: Cohort studies (prospective or retrospective) and randomised controlled trials conducted in unselected patients with infection treated exclusively by one- or two-stage revision and reporting re-infection outcomes within 2 years of revision will be retrieved by searching the following databases: MEDLINE, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and the WHO International Clinical Trials Registry Platform. Reference lists of relevant studies will be manually scanned and there will be email contact with investigators of grey literature and conference abstracts. Investigators will be invited to join the Global INFORM collaboration and share their individual level data. The primary outcome of the analyses will be incidence of re-infection within 2 years of commencement of revision surgery. Primary analyses will be conducted comparing the one-stage to the two-stage surgical revision. IPD analyses will be based on Cox proportional hazard (PH) models estimated for each study separately. Study-specific log hazard ratios will be combined using random-effects meta-analysis with fixed-effects meta-analysis in subsidiary analyses. Hazard ratios for re-infection according to different individual level characteristics such as sex, age groups, body mass index and comorbidities will also be assessed.

DISCUSSION: The analyses will enable a consistent approach to the definition of re-infection outcomes, more detailed analyses under a broader range of circumstances and exploration of potential sources of heterogeneity and produce much more valid and precise estimates of re-infection outcomes.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2015: CRD42015016664.

Original languageEnglish
JournalSystematic Reviews
Volume4
Issue number1
DOIs
Publication statusPublished - 25 Apr 2015

Structured keywords

  • Centre for Surgical Research

Keywords

  • Hip replacement
  • Individual participant data
  • Infection
  • Meta-analysis
  • One-stage
  • Revision
  • Two-stage

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