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Peer Reviewed Orthopaedic

NEWS RELEASE

Released: March 5, 2018

Defense Health Program
Department of Defense Peer Reviewed Orthopaedic Research Program
Funding Opportunities for Fiscal Year 2018 (FY18)

Although funds have not been appropriated for the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP), the PRORP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY18 funding opportunities.

FY18 PRORP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on Grants.gov in April 2018. Pre-application and application deadlines will be available when the Program Announcements are released. This pre-announcement should not be construed as an obligation by the Government, and funding of research projects received in response to these Program Announcements is contingent on the availability of Federal funds appropriated for the PRORP.

As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate, manages the Defense Health Program Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

The mission of the PRORP is to address the most significant gaps in care for the leading burden of injury for facilitating return-to-duty by funding innovative, high-impact, clinically relevant research to advance optimal treatment and rehabilitation from musculoskeletal injuries sustained during combat and combat-related activities.

Prolonged Field Care (PFC) has been identified as the number one capability gap across the Army. PFC includes field trauma care extended beyond doctrinal timelines until the patient can be transported from the point of injury to an appropriate level of care. In order to address this gap and prepare the orthopaedic field for the next conflict or mass event, the FY18 PRORP has identified several orthopaedic areas of focus for funding that will support patient care closer to the point of injury and to allow patients to more quickly return to duty/work.

The PRORP will solicit research applications that specifically address at least one of the following FY18 Focus Areas:

  • Animal Models - Develop animal models that replicate Prolonged Field Care-related injuries, including ischemia reperfusion injury and compartment syndrome.
  • Device Development - Develop offloading and stability devices (e.g., braces, casting) for ligamentous injuries, small extremity fractures, and /or other non-severe common battlefield musculoskeletal injuries for immediate return to duty.
  • Wound Infection - Evaluate and /or translate promising available clinical interventions in prevention and control of combat extremity wound infections (e.g., for long bone open fractures) to improve their durability to treat Service member injuries as close as possible to the point of injury. Projects that further develop novel wound protectants for this population will also be considered.
  • Treatment Techniques and Outcomes - Develop and /or evaluate optimal non-surgical and /or surgical treatment strategies and intervention delivery parameters (e.g., frequency, intensity, time, and intervention type) to rapidly remediate duty-limiting impairments, functional limitations, or barriers to full duty readiness following orthopedic injuries. Interventions may include, but are not limited to: combination therapies (simultaneous application of multiple treatment modalities), injections, dry needling, manual therapy, therapeutic exercise, or other techniques to return Service members to duty within 72 hours.
  • Surgical Care - Translate early research findings, in any of the below Surgical Care Areas, to humans.
    • Surgical Care Areas: Peripheral Nerve Injuries, Prevention of Heterotopic Ossification, Volumetric Muscle Loss, Extremity Fractures, Pelvic Ring Injuries, Compartment Syndrome, Gaps in Clinical Practice Guidelines (http://www.usaisr.amedd.army.mil/cpgs.html), Surgical Techniques to Optimize Gait, Soft Tissue Trauma, Osteoarthritis
  • Surgical Techniques and Outcomes - Evaluate optimal surgical treatment strategies, tools, and delivery parameters to improve functional outcomes of Service members who have sustained orthopaedic injuries. The proposed research should address at least one topic from the Surgical Care Areas (listed below), and strategies to return the patient to duty and potentially shorten recovery in theater.
    • Surgical Care Areas: Peripheral Nerve Injuries, Prevention of Heterotopic Ossification, Volumetric Muscle Loss, Extremity Fractures, Pelvic Ring Injuries, Compartment Syndrome, Gaps in Clinical Practice Guidelines (http://www.usaisr.amedd.army.mil/cpgs.html), Surgical Techniques to Optimize Gait, Soft Tissue Trauma, Osteoarthritis
  • Rehabilitation Techniques and Outcomes - Evaluate optimal rehabilitation treatment strategies, tools, and delivery parameters to improve functional outcomes for immediate return to duty of Service members who have sustained orthopaedic injuries.
  • Acute Pain - Evaluate promising available or emerging clinical interventions to control acute pain (e.g., analgesics, anti-inflammatory agents, nerve blocks) following orthopaedic injuries in the pre-hospital setting. Projects that investigate a pathway to enhance non-physician capabilities to deliver rapid, long lasting, analgesia with minimal cognitive side effects in an austere environment are encouraged.
  • Improved Surgical Interventions - Develop or optimize orthopaedic surgical interventions to support their use in the pre-hospital environment.
  • Tissue Regeneration:
    • Development and preclinical testing of therapies for volumetric muscle loss due to traumatically damaged tissues of the extremities.
    • Develop and /or evaluate regenerative medicine therapies (devices, drugs, biologics, and /or techniques) for traumatically injured tissues of the extremities.
    • Evaluate advanced regenerative medicine therapeutics for restoration of traumatically injured extremity tissues.

    The following FY18 PRORP award mechanisms are planned for release (note that Focus Area requirements vary by award mechanism):

Award Mechanism Eligibility Key Mechanism Elements Funding
Applied Research Award
  • Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Pre-application is required; Full application submission is by invitation only.
  • Supports applied research applications focused on advancing optimal treatment and restoration of function for military personnel with musculoskeletal injuries sustained during combat or combat-related activities.
  • Proposed research should be supported by preliminary data and have the potential to make significant advancements toward clinical translation.
  • Clinical trials are not allowed under this award mechanism.
  • Applications must address one the following FY18 PRORP Focus Areas:
    • Animal Models
    • Device Development
    • Wound Infection
    • Tissue Regeneration
  • Maximum funding of $750,000 for total costs
  • Maximum period of performance is 3 years
Clinical Trial Award
  • Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Pre-application is required; Full application submission is by invitation only.
  • Supports rapid implementation of clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries, or non-battle injuries that significantly impact unit readiness and return-to-duty/work rates
  • Funding must support a clinical trial and may not be used for preclinical research studies.
  • Collaboration with military researchers and clinicians is encouraged.
  • Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered.
  • Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date.
  • Applications must address one the following FY18 PRORP Focus Areas:
    • Surgical Techniques and Outcomes
    • Rehabilitation Techniques and Outcomes
    • Acute Pain
    • Improved Surgical Interventions
    • Tissue Regeneration
  • Maximum funding of $3 million (M) for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Clinical Translational Research Award
  • Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Pre-application is required; Full application submission is by invitation only.
  • Supports high-impact and/or emerging research that may or may not be ready for a full scale randomized controlled clinical trial.
  • Funding must support clinical research studies involving humans.
  • Preliminary or published data relevant to the proposed research project are required.
  • Collaboration with military researchers and clinicians is encouraged.
  • Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered.
  • Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date.
  • Applications must address one the following FY18 PRORP Focus Areas:
    • Treatment Techniques and Outcomes
    • Wound Infection
    • Surgical Care
    • Tissue Regeneration
  • Maximum funding of $2M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Applications must be submitted through the federal government's single-entry portal, Grants.gov. Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under "Email Subscriptions" on the eBRAP homepage at https://eBRAP.org. For more information about the PRORP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil