One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection (NCT02734134) | Clinical Trial Compass
CompletedNot 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared one-stage versus two-stage surgery for periprosthetic joint infections around the hip and knee — which approach did my doctor think performed better in terms of infection coming back, and which one would they recommend for my specific situation?
2Since this trial is now completed, have the results been published, and if so, what did they show about recurrence rates between the one-stage and two-stage procedures?
3The two-stage approach typically means more surgeries and a longer recovery with a temporary spacer — given my overall health and life situation, does my doctor think I could realistically handle that process, or would the one-stage option be more practical for me?
4Are there specific factors about my infection — like the type of bacteria involved, how long I've had the infection, or my immune system health — that would make one surgical approach clearly safer or more effective than the other?
5Since this trial is completed and no longer enrolling, are there other active studies or updated treatment protocols based on this research that my doctor thinks I should consider before deciding on a surgical plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.