Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06952738

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Not applicable- observational study

Study Details

Brief summary:

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.

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant

Study ID

NCT06952738

Start date

Oct 1, 2025

Status verified date

Dec, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Periprosthetic Fractures

This group will be all patients enrolled in the study: they will all have periprosthetic hip or knee fractures.

Interventions

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.

Primary outcome measure

  • Culture Positivity Rates [ Time Frame: From enrollment to the end of treatment at 14 days. ]

Central Contacts and Locations

Central contacts

Malik J Scott, BA

773-834-0822mjscott1@uchicago.edu

Vincent Buckman, BS

vincent.buckman@uchicagomedicine.org

Locations

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Sara Wallace, Doctor of Medicine

773-834-3531swallace2@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • Periprosthetic fractures
  • synovial fluid
  • prosthetic joint infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-12-22.