Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic InjuriesPRECISENCT03772730
Patient-Specific Precision Injury Signatures in Multiply Injured Orthopaedic Patients
An observational study of Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries, run by Major Extremity Trauma Research Consortium at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries
- How many people
- 320 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Mar 2019to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult (18-55) patients sustaining multiple injuries, including at least one qualifying orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia.
Who may be able to join
- Adult ages 18 years old to 55 years old inclusive;
- Direct admission to hospital from scene of injury, or if transferred, admitted no more than 6 hours from injury
- Full trauma activation with either direct admission to Intensive Care Unit (ICU) or other higher level of care, or taken directly to surgery and admitted to ICU after surgery;
- Sustaining at least one operative orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia with planned definitive fixation to occur prior to discharge.
Who cannot join
- Non-survivable head trauma.
- Signs of severe traumatic brain injury indicated by a GCS of < 7 at the time of admission and no improvement in the GCS by the time of consent.
- Spinal cord injury with likely permanent neurologic deficits
- Pre-existing organ dysfunction or failure prior to their injury, including but not limited to end-stage renal disease, liver failure, congestive heart failure, or severe COPD requiring home oxygen.
- Qualifying orthopaedic injury primarily a periarticular fracture (tibial pilon or plateau) with planned delay to definitive fixation for soft tissue reasons.
- Primary blood draw could not be obtained within 3 hours of presentation
Show all 9Show fewer
- Patient is pregnant
- Patient is a prisoner/incarcerated
- Patient or legally authorized representative (LAR) unable to provide consent prior to 48 hour blood draw.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Carolinas Medical Center
Durham, North Carolina, 28232
UT Health: The University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030
Methodist Hospital/Indiana University
Indianapolis, Indiana, 46202
University of Kentucky Medical Center
Lexington, Kentucky, 40536
University of Miami Ryder Trauma Center
Miami, Florida, 33101
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Washington Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: A Multi-Center, Prospective Observational Study to Evaluate the Use of Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients
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.
Read the 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;
- Multiple organ dysfunction
- Nosocomial infection
- Wound complications
- Resource utilization (ICU/hospital LOS, days on mechanical ventilation, discharge disposition)
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Multiply injured patients having at least one operative orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia with planned definitive fixation to occur prior to discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes recorded during 6month post injury medical record review
Number of occurrences of multiple organ dysfunction, nosocomial infection, wound complications, resource utilization and death as noted in medical record review.
Measured: 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start20 Mar 2019
- Primary completion30 Sep 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Todd McKinley, MD, Principal investigator, Indiana University/Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772730
- Sponsor's protocol ID
- 00008259
- Acronym
- PRECISE
- Status last verified
- Oct 2023
- First submitted
- 7 Dec 2018
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Observational Study to Evaluate the Use of Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients
- ClinicalTrials.gov ID
- NCT03772730
- Acronym / sponsor ID
- PRECISE / 00008259
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Multiple organ dysfunction
- Nosocomial infection
- Wound complications
- Resource utilization (ICU/hospital LOS, days on mechanical ventilation, discharge disposition)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Multiply injured patients having at least one operative orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia with planned definitive fixation to occur prior to discharge. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult (18-55) patients sustaining multiple injuries, including at least one qualifying orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia.
Key inclusion criteria (4 listed)
- Adult ages 18 years old to 55 years old inclusive;
- Direct admission to hospital from scene of injury, or if transferred, admitted no more than 6 hours from injury
- Full trauma activation with either direct admission to Intensive Care Unit (ICU) or other higher level of care, or taken directly to surgery and admitted to ICU after surgery;
- Sustaining at least one operative orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia with planned definitive fixation to occur prior to discharge.
Key exclusion criteria (9 listed)
- Non-survivable head trauma.
- Signs of severe traumatic brain injury indicated by a GCS of < 7 at the time of admission and no improvement in the GCS by the time of consent.
- Spinal cord injury with likely permanent neurologic deficits
- Pre-existing organ dysfunction or failure prior to their injury, including but not limited to end-stage renal disease, liver failure, congestive heart failure, or severe COPD requiring home oxygen.
- Qualifying orthopaedic injury primarily a periarticular fracture (tibial pilon or plateau) with planned delay to definitive fixation for soft tissue reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcomes recorded during 6month post injury medical record review
Time frame: 6 months post injury
Number of occurrences of multiple organ dysfunction, nosocomial infection, wound complications, resource utilization and death as noted in medical record review.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd McKinley, MD principal investigator
Indiana University/Methodist Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries, run by Major Extremity Trauma Research Consortium at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes recorded during 6month post injury medical record review (time frame: 6 months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.