Evaluation of mid-infrared spectral patterns and corresponding proteomic profile from serum for detecting fracture related infections in high-risk fractures.

Primary Investigator
R

Roman Natoli, MD

Primary Investigator

Administratively Closed
18 years - 85 years
All
Phase N/A
120 participants needed
1 Location

Brief description of study

The overall aim of this proposal is to identify a biomarker diagnostic strategy that can be implemented in patients sustaining fractures at high-risk for infection. This proposal will address the hypothesis that there is a biomarker signature that will be able to discriminate between patients who develop FRI compared to matched controls.

Detailed description of study

Venous blood samples will be obtained at four time points (T1-T4) that are otherwise part of routine standard of care follow-up for patient after fracture repair. The blood sample collections will be after definitive surgery for the injury which the patient is enrolled and prior to hospital discharge (T1), and postoperatively at 2-4 weeks (T2), 6-8 weeks (T3) and 3-4 months (T4). All four blood draws consist of a PAXgene RNA blood tube (2.5ml of blood), one 10mL EDTA blood tube, a 6ml red top serum tube, and an 8.5ml CPT tube for a total of 27ml per draw.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: open fracture
  • Age: 18 years - 85 years
  • Gender: All

Inclusion Criteria:
  • -Ages 18-85 years old and at least one of the following injuries: -Any open fracture -Closed tibia fractures with compartment syndrome (plateau, shaft, pilon) -Closed tibia fractures (plateau, shaft, pilon) undergoing staged fixation after ex-fix (min 3 days)
Exclusion Criteria:
  • and proximal to carpus or Foot distal to tarsal (ie, open metatarsal does not qualify) • Spine fractures • Pregnant • Prisoner • Known immunosuppressive state (lupus, cancer, Human Immunodeficiency Virus, Hepatitis C, rheumatologic disease, or any patient taking an immune-modulating medication) • Known presence of a separate source infection (e.g. urinary tract infection, pneumonia, sepsis, decubitus ulcer) • Systemic infection (bacteremia) • Pathologic fracture • Definitive orthopaedic surgical treatment included arthroplasty, percutaneous Kirshner wires or external fixation pins • Known venous thromboembolism

Updated on 29 Jun 2026. Study ID: ORTHO-AAOS-LONG-FRI, 15645

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