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Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial

Authors/contributors
Abstract
Objectives To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures. Design Pragmatic, parallel group, open label, randomised controlled trial. Setting High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018. Participants 140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision). Interventions A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure. Main outcome measures The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups. Results The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval −8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11 167 (95% confidence interval £638 to £21 696) at a £20 000 per quality adjusted life years threshold (£1.0; $1.1; €1.4). Conclusions At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery.
Publication
BMJ
Date
2022-10-31
Notes

Key Question: Is single stage revision surgery superior to two stage revision surgery for prosthetic joint infection of the hip, as assessed by patient-reported outcomes at 18 months?

Key Findings:

  • No significant difference was found between single stage and two stage revision surgery in the primary outcome of WOMAC score (measure of pain, stiffness and function) at 18 months.
  • Single stage revision had better WOMAC scores at 3 months compared to two stage, suggesting faster early recovery.
  • Rates of intraoperative complications were lower with single stage revision.
  • No significant differences were found in rates of reinfection or other secondary outcomes at 18 months.
  • Single stage revision was more cost-effective than two stage revision.

Clinical Implications:

  • For treatment of prosthetic hip joint infection requiring revision surgery, single stage and two stage procedures had similar patient-reported outcome scores at 18 months.
  • Single stage revision may allow faster early recovery and function. It was also associated with fewer intraoperative complications and greater cost-effectiveness.
  • When selecting revision surgery for prosthetic hip infection, surgeons should consider patient preferences, faster recovery with single stage, and the demonstrated cost-effectiveness of single stage revision.

Strengths:

  • Randomized controlled trial design
  • Good sample size and follow up rate
  • Use of validated patient-reported outcome measure as primary endpoint
  • Cost-effectiveness analysis
  • Reflects real-world practice across multiple centers

Limitations:

  • Lack of blinding of patients/surgeons, but reasonable given nature of interventions
  • No standardized definition for prosthetic joint infection
  • Moderate amount of missing data for some secondary outcomes
  • Primary outcome was subjective rather than a more objective endpoint like rates of reinfection
  • Limited follow-up duration of 18 months
Citation
1.
Blom AW, Lenguerrand E, Strange S, et al. Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial. BMJ. Published online October 31, 2022:e071281.