Patient-Specific Precision Injury Signatures in Multiply Injured Orthopaedic Patients
Condition: Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the use of precision methods that quantify injury
      and response to injury to predict how short-term clinical outcomes are affected by initial
      and staged orthopaedic interventions in multiply injured patients (MIPs) who sustain major
      orthopaedic trauma.
    

Detailed description: 
      There is currently a knowledge gap regarding in the treatment of the severely injured MIP, as
      clinicians are often challenged by when non-life threatening orthopaedic procedures should be
      performed. Information to guide orthopaedic interventions in MIPs is based primarily on
      resuscitation parameters and injury severity metrics.Lack of consensus among surgeons
      regarding choices of orthopaedic interventions reflects the paucity of data to form treatment
      decisions.

      This study will define the key parameters affecting these decisions in a quantitative manner
      by exploring the efficacy of a precision medicine approach to guide surgical decisions in
      multiply injured patients (MIPs) with skeletal trauma. According to the National Institutes
      of Health (NIH),36 precision medicine is "an emerging approach for disease treatment and
      prevention that takes into account individual variability in genes, environment, and
      lifestyle for each person." This approach will allow clinicians and researchers to predict
      more accurately which treatment and prevention strategies for a particular disease will work
      in which groups of people. The application of precision medicine will bring to bear
      evidence-based tools that can guide decisions facing the treating surgeons regarding the
      optimal timing of definitive fracture surgery after injury, as well as defining the magnitude
      of surgical intervention which may be pursued without engendering clinical complications.

      Specific Aim 1: Define groups of patients based on Precision Injury Signatures (mechanical
      and ischemic injury characteristics and immunologic response profile) that correspond to the
      following short term clinical outcomes;

        1. Multiple organ dysfunction

        2. Nosocomial infection

        3. Wound complications

        4. Resource utilization (ICU/hospital LOS, days on mechanical ventilation, discharge
           disposition)

        5. Death

      Hypothesis 1: Patients who develop complicated short term outcomes will demonstrate distinct
      Precision Injury Signatures compared to patients who have uncomplicated outcomes for injuries
      of similar magnitude.

      Specific Aim 2: Evaluate the impact of timing and magnitude of orthopaedic surgical
      interventions on progression of patient-specific physiologic and immunologic response.
      Describe changes in physiologic and immunologic response after initial and staged orthopaedic
      interventions.

      Hypothesis 2: Immunologic and physiologic response to surgery will be a function of initial
      Precision Injury Signature and timing/magnitude of orthopaedic surgical interventions.

      Specific Aim 3: To develop surgical decision rules related to timing of definitive
      orthopaedic intervention that optimize short term clinical outcomes.

      Hypothesis 3a: Initial Precision Injury Signatures can be used to identify orthopaedic trauma
      patients who are best treated with early definitive treatment or staged definitive
      intervention.

      Hypothesis 3b: Progression of Precision Injury Signatures can be used to determine optimal
      timing and choices of definitive orthopaedic interventions.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult (18-55) patients sustaining multiple injuries, including at least one qualifying
        orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia.
      
Biospecimen description: 
      Blood