One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection (NCT02734134) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
United States343 participantsStarted 2016-05-18
Plain-language summary
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 participate
Age range18 Years
SexALL
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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:
* 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 elu…