METRC – Major Extremity Trauma Research Consortium

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Showing: 39 of 39 studies

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BIOBURDEN: ClinicalTrials.gov ID NCT0146014; Complete; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD OETRP; Primary Objective Observational study to assess extremity wound bioburden at the time of definitive wound closure or coverage and its correlation with subsequent deep wound infection
FIXIT: ClinicalTrials.gov ID NCT01494519; Complete; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD OETRP; Primary Objective RCT to compare use of modern ring external fixation versus internal fixation for fracture stabilization
pTOG: ClinicalTrials.gov ID NCT00853489; Complete; Focus Area Reconstructive Surgery & Non-Surgical Management to Improve Bone Healing; Sponsor DoD OETRP; Primary Objective RCT to evaluate the use of recombinant protein in patients at high risk for nonunion
POvIV: ClinicalTrials.gov ID NCT01714596; Complete; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD PRORP; Primary Objective RCT to assess the efficacy of oral antibiotic therapy vs. intravenous antibiotics in the treatment of acute infection after fixation of fxs or fusion of joints
OUTLET: ClinicalTrials.gov ID NCT0106501; Complete; Focus Area Reconstructive Surgery & Non-Surgical Management to Improve Bone Healing; Sponsor DoD PRORP; Primary Objective Observational study comparing outcomes following limb salvage versus amputation of a severe distal tibia, ankle, and/or foot trauma
PACS: ClinicalTrials.gov ID NCT01561261; Complete; Focus Area Early Acute Management of the Orthopaedic Injury; Sponsor DoD PRORP; Primary Objective Observational study to develop a model for predicting likelihood of compartment syndrome based on clinical findings, continuous monitoring of intramuscular pressure and perfusion pressure, muscle oxygenation, and serum markers of muscle injury.
TAOS: ClinicalTrials.gov ID NCT01821976; Complete; Focus Area Optimization of Prosthetic & Orthotic Device Function, Durability, & Use; Sponsor DoD PRORP; Primary Objective RCT comparing outcomes for patients undergoing a transtibial amputation and receiving an end-bearing tibia-fibula synostosis versus a standard posterior flap procedure
TCCS: ClinicalTrials.gov ID NCT01907893; Complete; Focus Area Management of Pain & Psychosocial Sequelae; Sponsor DoD PRORP; Primary Objective Block randomized study to evaluate the effectiveness of the Trauma Collaborative Care (TCC) Intervention
RetroDEFECT: Complete; Focus Area Early Acute Management of the Orthopaedic Injury; Sponsor DoD PRORP; Primary Objective The primary purpose of this study is to characterize the methods of treatment currently being used to repair segmental defects > 1 cm with at least 50% cortical bone loss resulting from an open long bone fracture and to describe the outcomes and incidence of major complications associated with existing treatment methods.
VANCO: ClinicalTrials.gov ID NCT02227446; Complete; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD PRORP; Primary Objective RCT to compare efficacy of using local vancomycin powder in the prevention of surgical site infections
PRIORITI-MTF: ClinicalTrials.gov ID NCT02158884; Complete; Focus Area Optimization of Prosthetic & Orthotic Device Function, Durability, & Use; Sponsor DoD TATRC; Primary Objective A before-after prospective study to assess long-term benefits of the Intrepid Dynamic Exoskeletal Orthosis (IDEO) combined with a rigorous physical therapy program, the Return to Run Clinical Pathway
STREAM: ClinicalTrials.gov ID NCT02079714; Complete; Focus Area Other Focus Areas; Sponsor NIH-NIAMS; Primary Objective Observational study to evaluate the reliability, validity and responsiveness of the NIH Patient Reported Outcomes Measurement Information System (PROMIS) outcome tools
PAIN: ClinicalTrials.gov ID NCT01789216; Complete; Focus Area Management of Pain & Psychosocial Sequelae; Sponsor DoD PRORP; Primary Objective The objective of this study is to definitively resolve questions regarding the use of multimodal pharmacologic pain management for orthopedic trauma patients in the context of a multicenter, randomized clinical trial. We will test whether adjunctive analgesic therapy during the pre and peri-operative period, in addition to standard of care pain management, can improve overall pain control and pain related outcomes without increasing analgesic related side effects.
OXYGEN: ClinicalTrials.gov ID NCT01798810; Complete; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD PRORP; Primary Objective RCT to assess the efficacy of supplemental perioperative oxygen in the prevention of surgical site infections
ProFIT: ClinicalTrials.gov ID NCT03335657; Complete; Focus Area Optimization of Prosthetic & Orthotic Device Function, Durability, & Use; Sponsor DoD PRORP; Primary Objective Validation of an assessment of prosthetic fit and alignment for use in multicenter studies
METALS II: Complete; Focus Area Prediction, Prevention, & Amelioration of Secondary Conditions & Long-Term Physical Health Effects; Sponsor DoD PRORP; Primary Objective Retrospective cohort study to evaluate outcomes following major limb trauma sustained in Operations Enduring Freedom/ Iraqi Freedom/New Dawn
REPAIR: ClinicalTrials.gov ID NCT02746458; Complete; Focus Area Rehabilitation Interventions to Improve Functional Outcomes & Quality of Life; Sponsor DoD PRORP; Primary Objective RCT to compare efficacy of usual care physical therapy with usual care physical therapy combined with blood flow restricted training
NERVE: Complete; Focus Area Reconstructive Surgery & Non-Surgical Management to Improve Bone Healing; Sponsor DoD PRORP; Primary Objective Observational outcome study of peripheral nerve repair and reconstruction
PRECISE: ClinicalTrials.gov ID NCT03772730; Complete; Focus Area Early Acute Management of the Orthopaedic Injury; Sponsor DoD PRORP; Primary Objective 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 who sustain major orthopaedic trauma
EMS-BinD: ClinicalTrials.gov ID NCT03977168; Complete; Focus Area Early Acute Management of the Orthopaedic Injury; Sponsor DoD PRORP; Primary Objective To evaluate the effect of timing of placement of Circumferential Pelvic Compression (CPC) on resuscitative measures required for life-threatening pelvic ring injuries
LTE: ClinicalTrials.gov ID NA; Complete; Focus Area Prediction, Prevention, & Amelioration of Secondary Conditions & Long-Term Physical Health Effects; Sponsor DoD PRORP; Primary Objective To estimate the prevalence of secondary physical health effects at 3-5 years following major lower limb trauma and identify the factors related to the risk of developing secondary health effects; the prevalence of secondary health effects will be compared to age, gender and appropriate populations of civilians and Veterans
PilotBinD: Complete; Focus Area Early Acute Management of the Orthopaedic Injury; Sponsor DoD PRORP; Primary Objective A retrospective observational study of pelvic fractures treated across 23 trauma centers participating in the Major Extremity Trauma and Rehabilitation Consortium (METRC).
Prevent Clot: ClinicalTrials.gov ID NCT02984384; Complete; Focus Area Early Acute Management of the Orthopaedic Injury; Sponsor PCORI; Primary Objective RCT to compare Low Molecular Weight Heparin to Aspirin to determine which is the better therapy for preventing death and clinically significant blood clots in the lungs in patients who sustain trauma; PRE details
Clinical Guidelines: ClinicalTrials.gov ID NA; Complete; Focus Area Other Focus Areas; Sponsor DoD JWFMRP; Primary Objective Development of Clinical Practice Guidelines and Appropriate Use Criteria that address six clinical questions
CBPT: ClinicalTrials.gov ID NCT03335657; Complete; Focus Area Management of Pain & Psychosocial Sequelae; Sponsor DoD PRORP; Primary Objective Multisite RCT to determine efficacy of the cognitive-behavioral based physical therapy (CBPT) program in service members and civilians at risk for poor outcomes following traumatic lower-extremity injury compared to a standard education program
Preventable Death: Complete; Focus Area Other Focus Areas; Sponsor DoD BAA; Primary Objective A coordinated multidisciplinary multi-institutional effort within the civilian clinical sector to identify and characterize the causes of mortality from trauma in the pre-hospital setting. Approximately 3,000 pre-hospitals deaths will be reviewed by panels of experts
Weight Bearing: ClinicalTrials.gov ID NCT04028414; Ongoing; Focus Area Rehabilitation Interventions to Improve Functional Outcomes & Quality of Life; Sponsor DoD PRORP; Primary Objective RCT to compare early versus delayed weight bearing following ankle fracture without syndesmotic fixation
AlterG: ClinicalTrials.gov ID NCT03562364; Complete; Focus Area Rehabilitation Interventions to Improve Functional Outcomes & Quality of Life; Sponsor DoD PRORP; Primary Objective The overall objective is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.
SEXTANT: ClinicalTrials.gov ID NCT04678154; Ongoing; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD PRORP; Primary Objective To compare the infection rates of the current severe open fracture prophylactic antibiotic strategy to a revised SEXTANT treatment strategy designed to address the modern wound bioburden at the time of definitve wound closure.
TOBRA: ClinicalTrials.gov ID NCT04597008; Ongoing; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD PRORP; Primary Objective Compare the proportion of deep SSIs of the study injury within 365 days of definitive fracture fixation surgery in patients treated with local Vancomycin powder compared to those treated with a combination of local Vancomycin and Tobramycin powders.
UNION: ClinicalTrials.gov ID NCT05143476; Ongoing; Focus Area Reconstructive Surgery & Non-Surgical Management to Improve Bone Healing; Sponsor DoD PRORP; Primary Objective To define a serum protein based diagnostic for the progression and failure of fracture healing, though the identification of a set of serum proteins that appear at early times of biological healing and show a specific correlation with later radiological and functional signs used to define delayed healing and non-union.
Mobility Toolkit: ClinicalTrials.gov ID NCT04047030; Ongoing; Focus Area Rehabilitation Interventions to Improve Functional Outcomes & Quality of Life; Sponsor DoD PRORP; Primary Objective To test the implementation of the Mobility Toolkit in multiple trauma centers around the country and to generate normative data on lower-extremity injuries common among military and civilian patients
NSAID: ClinicalTrials.gov ID NCT05000281; Ongoing; Focus Area Management of Pain & Psychosocial Sequelae; Sponsor DoD PRORP; Primary Objective Evaluate the effect of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.
Stem Cell Pilot: Ongoing; Focus Area Optimization of Prosthetic & Orthotic Device Function, Durability, & Use; Sponsor DoD BAA; Primary Objective Observational study to determine if volar fibroblast injections are safe and effective at increasing epidermal thickness at the stump site in transtibial amputees
Volar Fibroblast: ClinicalTrials.gov ID NCT03947450; Ongoing; Focus Area Optimization of Prosthetic & Orthotic Device Function, Durability, & Use; Sponsor DoD OETRP; Primary Objective To determine if volar fibroblast injections are safe and effective at increasing epidermal thickness at the stump site in transtibial amputees
PEG Fusion: Ongoing; Focus Area Reconstructive Surgery & Non-Surgical Management to Improve Bone Healing; Sponsor AFIRM; Primary Objective
TUACS: Ongoing; Focus Area Early Acute Management of the Orthopaedic Injury; Sponsor DoD RESTORE; Primary Objective To test whether there are differences in the incidence of ACS in patients with severe leg injuries treated with active TUF compared to the control group.; UCS details
POvIV II: ClinicalTrials.gov ID NCT05699174; Starting; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD PRORP; Primary Objective Evaluate the effect of treatment of infected nonunion in bone fractures treated with revision fixation and either: (Group 1) operative debridement and PO antibiotic suppression for 6 weeks; or (Group 2) operative debridement and 6 weeks IV antibiotics.
iVAC: Starting; Focus Area Prevention & Management of Acute and Chronic Musculoskeletal Infections; Sponsor DoD PRORP; Primary Objective

Areas of Focus for METRC Research

Focus areas:

BIOBURDEN

FIXIT

pTOG

POvIV

OUTLET

PACS

TAOS

TCCS

RetroDEFECT

VANCO

PRIORITI-MTF

STREAM

PAIN

OXYGEN

ProFIT

METALS II

REPAIR

NERVE

PRECISE

EMS-BinD

LTE

PilotBinD

Prevent Clot

Clinical Guidelines

CBPT

Preventable Death

Weight Bearing

AlterG

SEXTANT

TOBRA

UNION

Mobility Toolkit

NSAID

Stem Cell Pilot

Volar Fibroblast

PEG Fusion

TUACS

POvIV II

iVAC