Detecting infections in fractures around joint implants
Investigating Periprosthetic Fracture Culture Positivity in Patients With Hip and Knee Arthroplasties
University of Chicago · NCT06952738
This project will test whether routine blood tests, synovial fluid analysis, and extended joint and tissue cultures can find infections in adults who have fractures around hip or knee replacements and need surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06952738 on ClinicalTrials.gov |
What this trial studies
Patients with periprosthetic fractures who require operative management will undergo standard preoperative imaging and inflammatory blood tests (CRP and ESR). Intraoperative synovial fluid will be analyzed for white blood cell count and PMN percentage, and three cultures from joint fluid and peri-implant tissue will be incubated for 14 days for aerobic, anaerobic, fungal, and AFB organisms. Samples and results will be interpreted alongside Musculoskeletal Infection Society (MSIS) criteria to identify infection and clinical factors that predict positive cultures. No additional advanced imaging will be obtained solely for the project and all testing follows the surgeons' standard-of-care protocols.
Who should consider this trial
Good fit: Adults over 18 with periprosthetic fractures around primary or revision hip or knee implants who require operative management and present to the University of Chicago during the October 2025 to October 2027 enrollment window.
Not a fit: Patients treated non-operatively, those with any prior prosthetic joint infection of the involved joint, or those presenting with a sinus tract are excluded and unlikely to benefit from the testing protocol.
Why it matters
Potential benefit: If successful, this approach could create clearer diagnostic rules for infection in periprosthetic fractures, reducing missed infections and guiding more appropriate surgical and antibiotic treatment.
How similar studies have performed: Prior work in prosthetic joint infection has shown that synovial analysis and prolonged cultures can improve pathogen detection, but applying these methods specifically to periprosthetic fractures is less well established and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>18 years old) with periprosthetic fractures around primary or revision hip or knee arthroplasty * Patients requiring operative management for these fractures (fixation or revision arthroplasty) * Patients presenting to the University of Chicago Medical Center during two (2) year period (October 2025 to October 2027) Exclusion Criteria: * Patients undergoing non-operative management for periprosthetic fractures * Any documented or reported history of past prosthetic joint infection of the involved joint * Sinus tract at the time of presentation at the involved joint
Where this trial is running
Chicago, Illinois
- The University of Chicago Medical Center — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Sara Wallace, MD — The University of Chicago Department of Orthopaedic Surgery
- Study coordinator: Malik J Scott, BA
- Email: mjscott1@uchicago.edu
- Phone: 773-834-0822
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.
Conditions: Periprosthetic Fracture Around Prosthetic Joint Implant, Periprosthetic fractures, synovial fluid, prosthetic joint infections