Congressionally Directed Medical Research Programs (CDMRP) -- Peer Reviewed Orthopaedic Research Program (PRORP) -- Clinical Translational Research Award

Funding Agency:
Department of Defense

Orthopaedic injuries have a profound impact on military readiness and return to work/activity/duty. In the military, extremity battle wounds comprise approximately 50% of injuries reported in the Department of Defense Trauma Registry. Additionally, orthopaedic injuries and conditions that occur outside of combat (e.g., during training, leisure activities, resultant from old injuries, etc.) present one of the greatest threats to the readiness of our Service Members and military. Early stabilization, treatment, and rehabilitation of orthopaedic injuries in both civilian and military populations have led to better outcomes, particularly in the prevention of secondary complications and in minimizing morbidity. Availability of orthopaedic care and treatment as early as possible, or as close to the point of injury as possible, also minimizes limb loss and affects military readiness. The PRORP is interested in supporting research that will have an impact on the lives of all individuals that have sustained a major musculoskeletal injury.

The PRORP Clinical Translational Research Award (CTRA) is intended to support high-impact and/or new/emerging clinical research that may not be ready for a full-scale randomized controlled clinical trial. Projects should demonstrate potential to impact the standard of care, both immediate and long-term, as well as contribute to evidence-based guidelines for the evaluation and care of military, Veterans, and all patients with orthopaedic injuries.

• One goal of the FY23 PRORP CTRA is to translate current and emerging techniques and interventions into the clinical space to better serve military patients. The health, functional abilities, and quality of life of individuals who have sustained an orthopaedic injury should be considered.

• Another goal is to identify the most effective diagnosis, treatment, rehabilitation, and prevention options available to support critical decision-making for patients, clinicians, other caregivers, and policymakers.

The FY23 PRORP CTRA differs from the FY23 PRORP Clinical Trial Award (CTA) in that the CTRA allows for clinical research projects that may or may not include a clinical trial, whereas the CTA is restricted to clinical trials only.

Deadlines:

• Required Pre-Application Deadline:  June 15, 2923

• Application Submission Deadline:  September 13, 2023

Agency Website

Areas of Interest

Applications submitted to this program announcement must address one of the following FY23 PRORP Clinical Translational Research Award Focus Areas. Selection of the appropriate Focus Area is the responsibility of the applicant.

1. 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 or avoid reinjury for common combat-related musculoskeletal injuries. Biomarker studies are excluded. The current standard of care must be noted. The rehabilitation strategy to be used in the proposed study must be specified, as applicable. Capabilities for diagnosis of underlying pathology and efficacy of interventions measurements are encouraged.

  • 1a. Battlefield Care: Strategies that can be utilized at or near the point of injury to allow an injured Service Member to remain on the battlefield or on mission without the need for evacuation. Treatment strategies that allow return to mission effectiveness within 30 days will be considered.
  • 1b. Return to Duty: Treatment strategies that can be utilized along the continuum of care and enable return to duty of the Service Member within 1 year of injury.

2. Volumetric Muscle Loss: Early clinical feasibility studies involving volumetric muscle loss.

3. Composite Tissue Regeneration: Advanced tissue regeneration therapeutics in composite tissue for the restoration of traumatically injured extremities. Isolated bone, cartilage, muscle, or nerve tissue engineering studies are excluded. Techniques aimed at improving outcomes following high-energy extremity trauma, with a focus on improving wound healing and neuromuscular recovery following composite tissue loss and segmental bone loss, are encouraged.

4. Osseointegration: Identification of best practices to address infection, rejection, and/or failure of percutaneous osseointegrated prosthetic limbs.

5. Prostheses and Orthoses: Development of high-performance novel prosthetic or orthotic devices designed to enhance whole-person performance and decrease pain in patients with amputation and limb salvage/impairment. Applicants are encouraged to consider multicenter studies that provide clinically relevant sample sizes, advanced limb orthoses that span at least one major joint (i.e., ankle, knee, and elbow), devices that focus on intuitive control and sensation, and compatibility with osseointegrated implants and/or integration of fail-safe devices where appropriate.

Eligibility Requirements

Independent investigators at all academic levels (or equivalent) may be named by the organization as the PI on the application. There is no limitation on the number of applications for which an investigator may be named as a PI. An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by or affiliated with an eligible organization

Amount

$1,500,000

Amount Description

The anticipated total costs budgeted for the entire period of performance for an FY23 PRORP Clinical Translation Research Award should not exceed $1.5M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Funding Type

Award
Grant

Eligibility

Faculty
Junior Faculty
Medical Fellow/Resident
Post Doctoral Fellows

Category

Medical
Medical - Clinical Science
Medical - Translational

External Deadline

June 15, 2023