Tag Archives: Orthopedics

Department of Defense Orthotics and Prosthetics Outcomes Research Program

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The FY20 Defense Appropriation Act provides $15 million to the Department of Defense Orthotics and Prosthetics Outcomes Research Program (OPORP) to support research on outcomes-based best practices through analysis of the merits of prosthetic and orthotic device options currently available, not on the development of new or the improvement of existing technology 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 Announcement/Funding Opportunity is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

The FY20 OPORP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website. Pre-application and application deadlines will be available when the Program Announcements are released. OPORP supports research that evaluates orthoses and/or prostheses using patient-centric outcomes relevant to Service Members and Veterans with limb loss and/or limb impairment. The intent of this research is to generate clinically useful evidence that will enhance and optimize patient outcomes. Applications submitted to the FY20 OPORP must address at least one of the following Focus Areas:

  • Orthoses or Prostheses Form: Optimize patient outcomes through the analysis and characterization of variables related to the form of currently available clinical options such as device size, shape, material, and/or configurations.
  • Orthoses or Prostheses Fit: Optimize patient outcomes related to human-device interface through the analysis of variables in currently available clinical options that facilitate fit-related metrics such as comfort and/or usability.
  • Orthoses or Prostheses Function: Optimize patient outcomes through the analysis of variables related to currently available device function such as device control, sensors, and passive or active response with respect to activities of daily living and other real-world activities.

Clinical Research Award – Letter of Intent due June 10, 2020

Independent investigators at all academic levels (or equivalent):

  • Supports research that evaluates orthoses and/or prostheses using patient-centric outcomes relevant to Service Members, Veterans, and other individuals with limb loss and/or limb impairment.
  • Supported research is intended to generate clinically useful evidence with potential to enhance and optimize patient outcomes.
  • Multidisciplinary collaboration among academics, industry, patient advocacy, the military Services, the Department of Veterans Affairs (VA), and/or other Federal Government agencies is highly encouraged.
  • Applications submitted to the FY20 OPORP CRA must address one or more of the FY20 OPORP Focus Areas.
  • Preclinical studies using animals are not allowed.
  • Clinical trials are not allowed.
  • The FY20 CRA offers two funding levels:
    • Funding Level 1: Maximum funding of $350,000 for total costs (direct plus indirect costs). Maximum period of performance is 2 years.
    • Funding Level 2: Maximum funding of $2,000,000 for total costs (direct plus indirect costs). Maximum period of performance is 4 years.

Clinical Trial Award – Letter of Intent due June 10, 2020

Independent investigators at all academic levels (or equivalent:

  • Supports implementation of clinical trials with the potential to have a significant impact on improving the health and well-being of Service Members, Veterans, and other individuals living with limb loss and/or limb impairment.
  • Supports clinical trials that evaluate orthoses and/or prostheses using patient-centric outcomes for the purpose of generating clinically useful evidence to enhance and optimize patient outcomes.
  • Multidisciplinary collaborations among academia, industry, patient advocacy, the Military Services, VA, and/or other Federal Government agencies is highly encouraged.
  • Applications submitted to the FY20 OPORP CTA must address one or more of the FY20 OPORP Focus Areas.
  • Preclinical research is not allowed.
  • The FY20 CTA offers two funding levels:
  • Funding Level 1
    • Funding Level 1 supports pilot clinical trials which are exploratory and involve limited human exposure with the potential to make significant advancement toward clinical translation. Preliminary data are allowed but not required. Maximum funding of $350,000 for total costs (direct plus indirect costs). Maximum period of performance is 2 years
    • Funding Level 2 supports clinical trials with the potential to make significant advancement toward clinical translation. Preliminary data relevant to the proposed clinical trial are required. Maximum funding of $4,000,000 for total costs (direct 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) 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 website 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 OPORP or other CDMRP-administered programs, please visit the CDMRP website.


Department of Defense Fiscal Year 2020 (FY20) Peer Reviewed Cancer Research Program and Peer Reviewed Orthopaedic Research Program Pre-Announcements

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The Department of Defense (DoD) recently released pre-announcements for the Fiscal Year 2020 (FY20) Department of Defense (DoD) Peer Reviewed Cancer Research Program and Peer Reviewed Orthopaedic Research Program managed by the office of Congressionally Directed Medical Research Programs (CDMRP) https://cdmrp.army.mil/pubs/press/cdmrp_presses.

Peer Reviewed Cancer Research Program:

  • Virtual Cancer Center – Director Award
  • Career Development Award – Fellow Option
  • Career Development Award – Scholar Option
  • Idea Award
  • Impact Award
  • Behavioral Health Science Award
  • Translational Team Science Award

Peer Reviewed Orthopaedic Research Program:

  • Applied Research Award
  • Clinical Trial Award
  • Clinical Translational Research Award

Descriptions of each of the anticipated funding opportunities, eligibility, key mechanism elements, and funding can be found in the Program pre-announcements.  FY20 pre-announcements can be found in the CDMRP home page features at https://cdmrp.army.mil. Subsequent notifications will be sent when the program announcements/funding opportunities are released.

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 United States Army Medical Research Materiel Command Congressionally Directed Medical Research Programs CDMRP – Research Funding for 2020

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The Fiscal Year 2020 Department of Defense Appropriations Act provides research funding for the following peer reviewed programs managed by the Department of Defense office of Congressionally Directed Medical Research Programs (CDMRP):

  • Amyotrophic Lateral Sclerosis Research Program
  • Autism Research Program
  • Bone Marrow Failure Research Program
  • Breast Cancer Research Program
  • Chronic Pain Management Research Program
  • Combat Readiness Medical Research Program
  • Duchenne Muscular Dystrophy Research Program
  • Epilepsy Research Program
  • Gulf War Illness Research Program
  • Hearing Restoration Research Program
  • Kidney Cancer Research Program
  • Joint Warfighter Medical Research Program
  • Lung Cancer Research Program
  • Lupus Research Program
  • Melanoma Research Program
  • Military Burn Research Program
  • Multiple Sclerosis Research Program
  • Neurofibromatosis Research Program
  • Orthotics and Prosthetics Outcomes Research Program
  • Ovarian Cancer Research Program
  • Pancreatic Cancer Research Program
  • Parkinson’s Research Program
  • Peer Reviewed Alzheimer’s Research Program
  • Peer Reviewed Cancer Research Program (14 Topics)
  • Peer Reviewed Medical Research Program (44 Topics)
  • Peer Reviewed Orthopaedic Research Program
  • Prostate Cancer Research Program
  • Rare Cancers Research Program
  • Reconstructive Transplant Research Program
  • Scleroderma Research Program
  • Spinal Cord Injury Research Program
  • Tick-Borne Disease Research Program
  • Tuberous Sclerosis Complex Research Program
  • Vision Research Program

Pre-announcements and comprehensive Program Announcements will be forthcoming. The pre-announcements will provide a general overview of the anticipated funding mechanisms. The Program Announcements will include detailed descriptions of funding mechanisms, evaluation criteria, submission requirements, and deadlines. Each Program Announcement may be downloaded from the Grants.gov website http://www.grants.gov, or the CDMRP website https://cdmrp.army.mil upon its release.

For email notification when pre-announcements and 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 CDMRP, our research programs, previous awardees, as well as research highlights and videos, please visit the website at https://cdmrp.army.mil.

Department of Defense Peer Reviewed Orthopaedic Research Program – Funding Opportunities for Fiscal Year 2019 (FY19)

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The Fiscal Year 2019 (FY19) Defense Appropriation provides $30 million (M) to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support the most significant gaps in care for the leading burden of injury and 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. 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 Materiel Command (USAMRMC).

FY19 PRORP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov. The PRORP will solicit research applications that specifically address at least one of the following FY19 Focus Areas:

1. Compartment Syndrome Models: Diagnostic and/or treatment strategies developed in a large animal model that replicates compartment syndrome. Model system should be clinically relevant and scientifically reproducible.

2. Limb Stabilization and Protection: Development of rapid limb stabilization and novel wound protectants for severely wounded limbs to enable transport at the point of need.

3. Retention on Duty Strategies: Development and/or optimization 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.)

4. Skin-implant Interface: Identification of best practices to address infection at the skin-implant interface for osseointegrated prosthetic limbs.

5. Translation of Early Findings: Translation of early research findings in orthopaedic surgical care topic areas (volumetric muscle loss, compartment syndrome, and soft tissue trauma) to move the research toward clinical trials and clinical practice.

6. Tissue Regeneration Therapeutics: Development of advanced tissue regeneration therapeutics in nerve, muscle, and/or composite tissue for the restoration of traumatically injured extremities (excludes isolated bone tissue engineering studies).

The following FY19 PRORP award mechanisms are planned for release (note that Focus Area requirements vary by award mechanism):

Additional information can be found here: https://cdmrp.army.mil/funding/prorp

  • Applied Research Award- Preproposal is due June 26, 2019
  • 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 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 FY19 PRORP Focus Areas: o Compartment Syndrome Models o Limb Stabilization and Protection o Retention on Duty Strategies o Skin Implant Interface
  • Maximum funding of $750,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is 3 years.
  • Clinical Trial Award – Preproposal due June 26, 2029
  • 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.
  • Collaboration with military researchers and clinicians is encouraged.
  • 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 FY19 PRORP Focus Areas:
    • Limb Stabilization and Protection o Retention on Duty Strategies
    • Translation of Early Findings 
    • Volumetric Muscle Loss
    • Compartment Syndrome
    • Soft Tissue Trauma
  • Funding Level 1:
  • Maximum funding of $2.5M 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 $3M maximum total costs and indirect costs • Maximum period of performance is 4 years.
  • Clinical Translational Research Award – Preproposal due June 26, 2019
  • Independent investigators at all academic levels (or equivalent) 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.
  • 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 the following FY19 PRORP Focus Areas: o Retention on Duty Strategies o Tissue Regeneration Therapeutics
  • Maximum funding of $2M for total costs (includes 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) 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 and other USAMRMC extramural funding opportunities can be obtained on the Grants.gov website 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 at https://eBRAP.org. For more information about the PRORP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).