One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

Completed · Not applicable

Conditions studied: Surgical Site Infection

In brief

The purpose of this study is to compare the outcomes of two different treatment options commonly used to manage periprosthetic joint infection (PJI), an infection around the artificial knee or hip.

Key facts

Study ID

NCT02734134

Run by

OrthoCarolina Research Institute, Inc.

People needed

343

Starts

2016-05-18

Expected to finish

2026-01-07

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Two positive cultures obtained from the prosthesis
• 3 of 5 criteria: (i) Elevated erythrocyte sedimentation rate (ESR) (>30mm/jr) and c-reactive protein (CRP) (>10mg/L) (ii) Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip (iii) Elevated synovial neutrophil percentage (>80%) (iv) One positive culture (v) Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400)
• Patients with a previous irrigation and debridement for periprosthetic infection

You may not qualify if…

• Culture negative infections whereby the infecting organism has not identified
• 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
• Fungal infections
• Resistant organisms not sensitive to available IV antibiotics, oral antibiotics, or heat stable antibiotic additives to bone cement with documented elution characteristics
• Revision surgery or previous two-stage reimplant
• HIV positive patients or patients on chemotherapy

Where it is running

• Midwest Orthopaedics at Rush University Medical Center — Chicago, Illinois, United States
• Hospital for Special Surgery — New York, New York, United States
• OrthoCarolina Research Institue — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Rothman Institute at Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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