Tag Archives: Orthopaedic Injury

Department of Defense Peer Reviewed Orthopaedic Research Program

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The FY20 Defense Appropriations Act provides funding to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support innovative, high-impact, clinically-relevant research to advance optimal treatment and rehabilitation from musculoskeletal injuries. 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 (DHP) 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) at the U.S. Army Medical Research and Development Command (USAMRDC).

The FY20 PRORP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website. 

Applications submitted to the FY20 PRORP must address one or more of the following FY20 Focus Areas:

  • Compartment Syndrome: Novel treatment strategies to improve current diagnoses for compartment syndrome. Alternatives to intracompartmental pressure measurements are encouraged.
  • Limb Stabilization and Protection: Development and/or clinical assessment of rapid limb stabilization and novel wound protectants for severely wounded limbs to enable transport at the point of need.
  • Orthotic Devices: Refinement of high-performance novel orthotic devices designed to enhance whole person performance and decrease pain in patients with limb salvage and impairment.
  • Osseointegration: Identification of best practices to address infection, rejection, and/or failure of percutaneous osseointegrated prosthetic limbs. 
  • Retention Strategies: Development, optimization, and/or validation of battlefield-feasible diagnostic capabilities, decision support tools, interventions, and/or rehabilitation strategies that can facilitate retention on duty for common combat-related musculoskeletal injuries.  Biomarker studies are excluded.  The current standard of care must be noted.  The rehabilitation strategy and the standard of care must be specified, as applicable.
    • Point of Injury: Battlefield-feasible strategies that can be utilized at or near the point of injury to allow an injured Service member to remain on duty and stay on mission without the need for immediate evacuation
    • Point of Duty: Strategies that can be utilized along the continuum of care to allow an injured Service member to return to duty without separation from Service.
  • Tissue Regeneration Therapeutics: Development of advanced tissue regeneration therapeutics in nerve, muscle (to include volumetric muscle loss), and/or composite tissue for the restoration of traumatically injured extremities.  Isolated bone or cartilage tissue engineering studies are excluded.
  • Translation of Early Findings: Translation of early research findings in the orthopaedic surgical care topic areas listed below to move the research toward clinical trials and clinical practice.
    • Soft Tissue Trauma: Strategies to develop and/or identify musculoskeletal extremity soft tissue trauma treatments for anterior cruciate ligament (ACL) or shoulder instability only, to optimize return to duty, work, or reintegration
    • Fracture-Related Infection: Strategies to decrease the burden of fracture-related infections (may include prevention, early detection, or improved eradication).  Alternatives to systemic and/or local antibiotic delivery are encouraged. 

https://cdmrp.army.mil/funding/prorp

Applied Research Award – Preproposal due May 27, 2020. Independent investigators at all academic levels (or equivalent):

  • 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 individuals with musculo-skeletal injuries sustained during combat or combat-related activities, and non-battle injuries that impact unit readiness and the ability to return to duty/work.
  • Proposed research should be supported by preliminary data and have the potential to make significant advancements toward clinical translation.
  • Clinical research and clinical trials are not allowed under this award mechanism.
  • Applications must address one of the following FY20 PRORP Focus Areas:
    • Limb Stabilization and Protection
    • Retention Strategies
      • Point of Injury
      • Return to Duty
  • Osseointegration

Maximum funding of $725,000 for total costs (includes direct and indirect costs). Maximum period of performance is 3 years.

Clinical Trial Award – Preproposal due May 27, 2020.Independent investigators at all academic levels (or equivalent):

  • 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.
  • 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 FY20 PRORP Focus Areas:
    • Limb Stabilization and Protection
    • Retention Strategies
      • Point of Injury
      • Return to Duty
    • Translation of Early Findings
      • Soft Tissue Trauma
      • Fracture-Related Infection

Funding Level 1:Maximum funding of $2.25M for total costs. (includes direct and indirect costs). Maximum period of performance is 4 years.

Funding Level 2 (Translation of Early Findings – Soft Tissue Trauma Focus Area with Rehabilitation Option): Maximum funding of $2.75M for total costs (includes direct and indirect costs). Maximum period of performance is 4 years.

Clinical Translational Research Award – Preproposal is due May 27, 2020. Independent investigators at all academic levels (or equivalent):

  • Pre-application is required; full application submission is by invitation only.
  • Supports high-impact and/or new/emerging clinical 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.
  • Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 12 months of the award date.
  • Applications must address one of the following FY19 PRORP CTRA Focus Areas:
    • Retention Strategies
      • Point of Injury
      • Return to Duty
    • Tissue Regeneration Therapeutics
    • Compartment Syndrome
    • Osseointegration
    • Orthotic Devices

Maximum funding of $1.5M for total costs (including direct and 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) prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions 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 and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov by performing a basic search using CFDA Number 12.420. 

For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage. For more information about the PRORP or other CDMRP-administered programs, please visit the CDMRP website.

Defense Health Program Department of Defense Peer Reviewed Orthopaedic Research Program Anticipated Funding Opportunities for Fiscal Year 2020 (FY20)

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The FY20 Defense Appropriations Act provides funding to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support innovative, high-impact, clinically-relevant research to advance optimal treatment and rehabilitation from musculoskeletal injuries.  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 (DHP) 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) at the U.S. Army Medical Research and Development Command (USAMRDC).

The PRORP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY20 funding opportunities.  This pre-announcement should not be construed as an obligation by the Government.  The FY20 PRORP Program Announcements and General Application Instructions for the following award mechanisms will be posted on the Grants.gov website.  Pre-application and application deadlines will be available when the Program Announcements are released. 

Applications submitted to the FY20 PRORP must address one or more of the following FY20 Focus Areas:

  1. Compartment Syndrome: Novel treatment strategies to improve current diagnoses for compartment syndrome. Alternatives to intracompartmental pressure measurements are encouraged.
  2. Limb Stabilization and Protection: Development and/or clinical assessment of rapid limb stabilization and novel wound protectants for severely wounded limbs to enable transport at the point of need.
  3. Orthotic Devices: Refinement of high-performance novel orthotic devices designed to enhance whole person performance and decrease pain in patients with limb salvage and impairment.
  4. Osseointegration: Identification of best practices to address infection, rejection, and/or failure of percutaneous osseointegrated prosthetic limbs.
  5. Retention Strategies: Development, optimization, and/or validation of battlefield-feasible diagnostic capabilities, decision support tools, interventions, and/or rehabilitation strategies that can facilitate retention on duty for common combat-related musculoskeletal injuries.  Biomarker studies are excluded.  The current standard of care must be noted.  The rehabilitation strategy and the standard of care must be specified, as applicable.
    1. Point of Injury: Battlefield-feasible strategies that can be utilized at or near the point of injury to allow an injured Service member to remain on duty and stay on mission without the need for immediate evacuation.
    2. Point of Duty: Strategies that can be utilized along the continuum of care to allow an injured Service member to return to duty without separation from Service.
  6. Tissue Regeneration Therapeutics: Development of advanced tissue regeneration therapeutics in nerve, muscle (to include volumetric muscle loss), and/or composite tissue for the restoration of traumatically injured extremities.  Isolated bone or cartilage tissue engineering studies are excluded.
  7. Translation of Early Findings: Translation of early research findings in the orthopaedic surgical care topic areas listed below to move the research toward clinical trials and clinical practice.
    1. Soft Tissue Trauma: Strategies to develop and/or identify musculoskeletal extremity soft tissue trauma treatments for anterior cruciate ligament (ACL) or shoulder instability only, to optimize return to duty, work, or reintegration.
    2. Fracture-Related Infection: Strategies to decrease the burden of fracture-related infections (may include prevention, early detection, or improved eradication).  Alternatives to systemic and/or local antibiotic delivery are encouraged. 

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 and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

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.army.mil).

Additional information, including the award mechanisms, can be found on the CDMRP site.

Department of Defense Peer Reviewed Orthopaedic Research Program – Funding Opportunities for Fiscal Year 2018

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FY18 PRORP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov. 

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 released (note that Focus Area requirements vary by award mechanism):

http://cdmrp.army.mil/funding/prorp

Applied Research Award – Preproposal due July 30, 2018

  • 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 – Preproposal due July 30, 2018

  • 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 – Preproposal due July 30, 2018

  • 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 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.  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 (http://cdmrp.army.mil).

Point of Contact:

CDMRP Help Desk
301-682-5507
help@eBrap.org