One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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
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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