Comparing two types of spacers for treating knee joint infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares two treatment methods for chronic periprosthetic joint infections following total knee arthroplasty. One method uses an all-cement articulating spacer, while the other employs a durable, real-component articulating spacer. Patients will be randomly assigned to one of the two cohorts, and their outcomes will be assessed through preoperative patient-reported outcomes questionnaires administered via iPad or online. The goal is to determine which spacer type leads to better infection management and patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Northwestern Medicine
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Adam I Edelstein, MD — Assistant Professor of Orthopaedic Surgery
• Study coordinator: Melissa J Shauver, MPH
• Email: melissa.shauver@northwestern.edu
• Phone: 312-472-6024

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.