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Recruiting

NCT Number: NCT06952738

Investigating Periprosthetic Fracture Cultures in Arthroplasty

This study aims to improve how doctors diagnose infections in patients with broken bones around joint replacements. Currently, there are no clear guidelines to help determine when an infection is present, making treatment decisions difficult. By studying how often infections are found through lab tests and identifying factors that predict infection, the investigators hope to create better ways to diagnose and care for these patients.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Sara Wallace, Doctor of Medicine

CONTACT

[email protected]

773-834-3531

About this study

All steps in the protocol will be completed under the standard of care for our hospital's orthopedic joints and trauma surgeons. All patients identified under the inclusion criteria will undergo preoperative imaging. In accordance with current standards of care, patients with periprosthetic fractures (PPFs) around the hip will receive three views of X-rays of the hip and femur as well as the anterior-posterior view of the pelvis. Likewise, patients with PPFs around the knee will undergo X-rays that include the knee and femur. No advanced imaging (Computed Tomography, Magnetic Resonance Imaging, etc.) will be obtained for the purpose of this study.

Preoperative laboratory analysis will include C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) as inflammatory markers. Intraoperative synovial fluid analysis will be performed using synovial white blood cell (WBC) count and polymorphonuclear (PMN) percentage. Three cultures will be obtained from the involved joint fluid and tissue, and incubated for 14 days for analysis of aerobic, anaerobic bacterial cultures, fungal and acid-fast bacilli (AFB) analysis. The cultures will be collected from synovial fluid, peri-implant femoral synovium/periosteum, peri-implant tibial or acetabular synovium/periosteum. These laboratory tests and cultures are part of the standard protocol our surgeons have determined for their patient care.

Based on the Musculoskeletal Infection Society (MSIS) criteria for positive histology intraoperative histology will be performed utilizing frozen section analysis. These slides will be isolated from synovium, peri-implant femoral synovium/periosteum, and peri-implant tibial or acetabular synovium/periosteum. Additional cultures may be sent at discretion of surgeon but would not be included in analysis.

Per institutional protocol, preoperative cefazolin and vancomycin will be administered intravenously and continued for 24 hours perioperatively. Patients who are allergic to vancomycin will receive daptomycin, and those who are allergic to beta-lactam drugs including cephalosporins will be given gentamicin. No intra-articular antibiotics will be routinely administered.

All cultures will be followed until final. If cultures become positive, our institutional infectious disease (ID) department will be consulted for further recommendations and consideration for treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable- observational study

Other

The investigators are only looking to see the rate of positivity of the cultures as well as what the organisms that are found in the cultures are.

Primary outcomes

  1. Culture Positivity Rates

    Time frame: From enrollment to the end of treatment at 14 days.

    This outcome measure is the percentage of cultures that grow organisms among the population

Secondary outcomes

  1. Rate of Complications

    Time frame: From date of surgery to one year after the specific participant's surgery.

    Number of participants with surgery-related complications within one year after their surgeries.

  2. Culture Organisms

    Time frame: From surgery date to 14 days after surgery.

    The names, number, and frequency of organisms being found in the cultures.

  3. Treatments Used

    Time frame: From enrollment to one year after surgery.

    The list of antibiotics used for treating organisms found to be positive in the cultures.

Study contacts

Contact information is provided by the study sponsor or research team.

Malik J Scott, BA

CONTACT

[email protected]

773-834-0822

Vincent Buckman, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Investigating Periprosthetic Fracture Culture Positivity in Patients With Hip and Knee Arthroplasties

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 1, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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