Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03772730 |
| Other study ID # |
00008259 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 20, 2019 |
| Est. completion date |
May 30, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Major Extremity Trauma Research Consortium |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
