Comparing two types of spacers for treating knee joint infections
Durable, Real-component Antibiotic Spacers vs All-cement Articulating Spacers for the Treatment of Periprosthetic Knee Infection
This study is testing which type of spacer works better for treating knee joint infections in patients who have had knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 153 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06293352 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with chronic periprosthetic joint infections after a primary total knee arthroplasty who are scheduled for explant and placement of an antibiotic spacer.
Not a fit: Patients with infections at the site of revision, significant soft tissue compromise, or those unable to consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options for patients with knee joint infections, potentially leading to better recovery and fewer complications.
How similar studies have performed: While the approach of using different types of spacers is established, this specific comparison has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.