Clinical trial NCT06952738: Investigating Periprosthetic Fracture Cultures in Arthroplasty
Official title: Investigating Periprosthetic Fracture Culture Positivity in Patients With Hip and Knee Arthroplasties
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Periprosthetic Fracture Around Prosthetic Joint Implant
Keywords: Periprosthetic fractures
synovial fluid
prosthetic joint infections
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Culture Positivity Rates
timeFrame: From enrollment to the end of treatment at 14 days.
Secondary outcomes:
measure: Rate of Complications
timeFrame: From date of surgery to one year after the specific participant's surgery.
measure: Culture Organisms
timeFrame: From surgery date to 14 days after surgery.
measure: Treatments Used
timeFrame: From enrollment to one year after surgery.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: The University of Chicago Department of Orthopaedic Surgery
name: Sara Wallace, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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