Real-component Vs All-cement Articulating Spacers for Periprosthetic Knee Infection
Launched by NORTHWESTERN UNIVERSITY · Feb 28, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different ways to treat infections that can occur in artificial knee joints after surgery. When an infection doesn’t go away with antibiotics, doctors usually perform a two-stage procedure: first, they remove the artificial knee, clean the area, and place an antibiotic spacer, which helps fight the infection but allows limited knee movement. After the infection is cleared, a second surgery is needed to replace the spacer with a new artificial knee. Alternatively, there’s a one-stage approach where the doctor removes the infected knee and replaces it immediately with a new artificial knee that uses special cement containing antibiotics. This method allows for better knee function while healing but may also need a future replacement.
The trial is looking for patients aged 65 to 74 who have been diagnosed with a chronic infection in their artificial knee joint after a previous knee surgery. Participants will be randomly assigned to either the one-stage or two-stage procedure and will be followed for five years to see how well their knees function, how much pain they experience, and how satisfied they are with their treatment. This study aims to find out which option patients prefer and which one leads to better long-term outcomes. If you think you might be eligible and are interested in participating, your doctor can provide more information.
Gender
ALL
Eligibility 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
About Northwestern University
Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Patients applied
Trial Officials
Adam I Edelstein, MD
Principal Investigator
Assistant Professor of Orthopaedic Surgery
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported