Detecting infections in fractures around joint implants
Official title: Investigating Periprosthetic Fracture Culture Positivity in Patients With Hip and Knee Arthroplasties
Run by University of Chicago · NCT06952738 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06952738 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.