
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.
About
Protocol Description
This is a multi-center randomized controlled clinical trial to directly compare the outcomes of the one-stage versus two-stage exchange arthroplasty in the treatment of chronic periprosthetic total joint infections of the hip and knee. The one-stage exchange arthroplasty may carry a similar success rate in the treatment of chronic periprosthetic infections while avoiding the known problems associated with the two-stage exchange arthroplasty. Patients that meet the outlined inclusion and exclusion criteria will be offered enrollment into this study. Those who elect to participate will be randomly assigned to one of the two treatment arms and followed for 2 years.

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
