Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT02734134
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
* 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 elution characteristics
* Revision surgery or previous two-stage reimplant
* HIV positive patients or patients on chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02734134
Study Brief:
Protocol Section:
NCT02734134