One Stage versus Two Stage for Periprosthetic Hip and Knee Infection

This is a clinical trial to investigate the outcome of the one-stage and two-stage exchange arthroplasty for the management of patients with chronic periprosthetic total joint infections of the hip and knee.

Eligibility Criteria

Inclusion Criteria

  • Patients >18 years old
  • Patients who speak English and are willing to sign the consent form
  • Patients with chronic infection of a total knee or total hip arthroplasty, defined as:
    • A sinus communicating with the prosthesis, OR
    • Two positive cultures obtained from the prosthesis, OR
    • Three of five criteria (check all that apply):
      • Elevated ESR (>30mm/jr) and CRP (>10mg/L)
      • Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on leukocyte esterase strip
      • Elevated synovial neutrophil percentage (>80%)
      • One positive culture
      • Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in five high-power fields x400)

Exclusion Criteria

  • Patients with systemic sepsis who require emergent surgery
  • Patients with extensive soft tissue involvement that would preclude the closure of
  • the wound after reimplantation if the patient were to undergo the one-stage
  • exchange
  • Patients with acute PJI or acute hematogenous PJI, defined as:
    • Presentation of systems <4-weeks from index procedure
    • Presentation of systems <4-week duration
  • Revision surgery or previous two-stage re-implant
  • HIV positive patients or patients on chemotherapy
  • Culture negative infections whereby the infecting organism has not identified.
  • Fungal infections
  • Resistant organisms not sensitive to available IV antibiotics, oral antibiotics or heat-stable antibiotic additives to bone cement with documented elution characteristics

Primary Investigator

Joseph Moskal, M.D., is Carilion Clinic's chairman of the Department of Orthopaedic Surgery, chief of Adult Reconstruction and fellowship director of the Adult Reconstruction (Hip and Knee) program at Carilion Clinic; and professor and chairman of the Department of Orthopaedic Surgery at the Virginia Tech Carilion School of Medicine.

Contact Information

Andrea A. Yu-Shan, B.S.

Clinical Research Coordinator

 

Lauren E. Nogueira

Medical Scribe and Clinical Research Assistant