For Healthcare Professionals

One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Patients >18 years old
  2. 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:


  1. A sinus communicating with the prosthesis
  2. Two positive cultures obtained from the prosthesis
  3. 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)
  4. Patients with a previous irrigation and debridement for periprosthetic infection

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Culture negative infections whereby the infecting organism has not identified
  2. Patients with systemic sepsis who require emergent surgery
  3. 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:


  1. Presentation of systems <4 weeks from index procedure
  2. Presentation of systems <4 week duration
  3. Fungal infections
  4. Resistant organisms not sensitive to available IV antibiotics, oral antibiotics, or heat stable antibiotic additives to bone cement with documented elution characteristics
  5. Revision surgery or previous two-stage reimplant
  6. HIV positive patients or patients on chemotherapy

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Surgical Site Infection

Age (in years)

18+

Phase

Not Applicable

Participants needed

343

Est. Completion Date

Dec 31, 2024

Treatment type

Interventional


Sponsor

OrthoCarolina Research Institute, Inc.

ClinicalTrials.gov identifier

NCT02734134

Study number

1106

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