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Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection

RecruitingNAAges 18 Years - anyAllNorthwestern University
NCT06293352 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In the US, if an infection in an artificial knee joint doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, the surgeon will remove the artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics into the knee space continuously over time. The spacer allows only very basic function of the knee. The patient may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, the surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in. There is anoth

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients diagnosed with a chronic periprosthetic joint infection after a primary total knee arthroplasty with plan for explant and placement of an antibiotic spacer * PJI defined according to Musculoskeletal Infection Society (MSIS) 2018 Consensus Criteria Exclusion Criteria: * Patients who are unable to consent * Infection at site of revision TKA * Soft tissue envelope compromise * Allergies to study materials (cement, vancomycin, tobramycin) * Incompetent extensor mechanism * Extensive bone loss Randomization-specific exclusion criteria * Extensive soft tissue defect * Extensor mechanism compromise
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What it tests

  • All-cement articulating spacer
  • Durable, real-component articulating spacer
  • Rigid Spacer
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Where

1 site
Northwestern Medicine
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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