Investigating Periprosthetic Fracture Cultures in Arthroplasty

December 15, 2025 updated by: University of Chicago

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This population would include all consenting patients older than 18 years who present to the University of Chicago Medical Center with periprosthetic hip or knee fractures and will require operative management of the fracture or infection.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periprosthetic Fractures
This group will be all patients enrolled in the study: they will all have periprosthetic hip or knee fractures.
Other: Not applicable- observational study
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 14 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of surgery to one year after the specific participant's surgery.
Culture Organisms
Time Frame: From surgery date to 14 days after surgery.
The names, number, and frequency of organisms being found in the cultures.
From surgery date to 14 days after surgery.
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.
From enrollment to one year after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Sara Wallace, MD, The University of Chicago Department of Orthopaedic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB25-0498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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