Investigating Periprosthetic Fracture Cultures in Arthroplasty

NCT06952738 | Recruiting

• 1 other identifier: IRB25-0498
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Periprosthetic fractures; synovial fluid; prosthetic joint infections

Outcome Measures

Primary Outcomes (1)

• Culture Positivity Rates

  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 Outcomes (3)

• Rate of Complications

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

• Culture Organisms

  From surgery date to 14 days after surgery.

• Treatments Used

  From enrollment to one year after surgery.

Study Arms (1)

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

Interventions

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.

Periprosthetic Fractures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (11)

• Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, Shohat N. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty. 2018 May;33(5):1309-1314.e2. doi: 10.1016/j.arth.2018.02.078. Epub 2018 Feb 26.

  PMID: 29551303 BACKGROUND

• McArthur BA, Abdel MP, Taunton MJ, Osmon DR, Hanssen AD. Seronegative infections in hip and knee arthroplasty: periprosthetic infections with normal erythrocyte sedimentation rate and C-reactive protein level. Bone Joint J. 2015 Jul;97-B(7):939-44. doi: 10.1302/0301-620X.97B7.35500.

  PMID: 26130349 BACKGROUND

• Schinsky MF, Della Valle CJ, Sporer SM, Paprosky WG. Perioperative testing for joint infection in patients undergoing revision total hip arthroplasty. J Bone Joint Surg Am. 2008 Sep;90(9):1869-75. doi: 10.2106/JBJS.G.01255.

  PMID: 18762646 BACKGROUND

• Shah RP, Plummer DR, Moric M, Sporer SM, Levine BR, Della Valle CJ. Diagnosing Infection in the Setting of Periprosthetic Fractures. J Arthroplasty. 2016 Sep;31(9 Suppl):140-3. doi: 10.1016/j.arth.2015.08.045. Epub 2016 Mar 17.

  PMID: 27067465 BACKGROUND

• Preston S, Somerville L, Lanting B, Howard J. Are Nucleated Cell Counts Useful in the Diagnosis of Infection in Periprosthetic Fracture? Clin Orthop Relat Res. 2015 Jul;473(7):2238-43. doi: 10.1007/s11999-015-4162-8.

  PMID: 25631172 BACKGROUND

• Chevillotte CJ, Ali MH, Trousdale RT, Larson DR, Gullerud RE, Berry DJ. Inflammatory laboratory markers in periprosthetic hip fractures. J Arthroplasty. 2009 Aug;24(5):722-7. doi: 10.1016/j.arth.2008.05.026. Epub 2008 Sep 11.

  PMID: 18789633 BACKGROUND

• Austin MS, Ghanem E, Joshi A, Lindsay A, Parvizi J. A simple, cost-effective screening protocol to rule out periprosthetic infection. J Arthroplasty. 2008 Jan;23(1):65-8. doi: 10.1016/j.arth.2007.09.005.

  PMID: 18165031 BACKGROUND

• van den Kieboom J, Tirumala V, Xiong L, Klemt C, Kwon YM. Concomitant Hip and Knee Periprosthetic Joint Infection in Periprosthetic Fracture: Diagnostic Utility of Serum and Synovial Fluid Markers. J Arthroplasty. 2021 Feb;36(2):722-727. doi: 10.1016/j.arth.2020.08.029. Epub 2020 Aug 18.

  PMID: 32893059 BACKGROUND

• Barberis L, Abdelrahman T, Driscoll DA, Dasci MF, Gehrke T, Citak M. Unexpected Positive Cultures in Hip and Knee Periprosthetic Fractures. J Arthroplasty. 2024 Jul;39(7):1834-1839. doi: 10.1016/j.arth.2024.01.030. Epub 2024 Jan 18.

  PMID: 38244640 BACKGROUND

• Shichman I, Roof M, Askew N, Nherera L, Rozell JC, Seyler TM, Schwarzkopf R. Projections and Epidemiology of Primary Hip and Knee Arthroplasty in Medicare Patients to 2040-2060. JB JS Open Access. 2023 Feb 28;8(1):e22.00112. doi: 10.2106/JBJS.OA.22.00112. eCollection 2023 Jan-Mar.

  PMID: 36864906 BACKGROUND

• Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.

  PMID: 30180053 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will be collecting synovial fluid and tissue cultures from hips and knees with periprosthetic fractures and will be monitoring the cultures for 14 days.

MeSH Terms

Conditions

Periprosthetic Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Sara Wallace, MD

  The University of Chicago Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malik J Scott, BA

CONTACT

773-834-0822; mjscott1@uchicago.edu

Vincent Buckman, BS

CONTACT

vincent.buckman@uchicagomedicine.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)