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Congressionally Directed Medical Research Programs (CDMRP) -- Peer Reviewed Orthopaedic Research Program (PRORP) -- Clinical Translational Research Award
The PRORP CTRA is intended to support high-impact and/or new/emerging clinical research that may or 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, Veteran, and all patients with orthopaedic injuries.
• One goal of the FY21 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 FY21 PRORP CTRA differs from the FY21 PRORP Clinical Trial Award (CTA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only. Applications to the FY21 PRORP Clinical Translational Research Award mechanism must support clinical research and may not be used for animal research. The proposed studies may be interventional and may involve some retrospective data analysis. Note that purely retrospective or database-related research is not allowed under this funding opportunity. Small pilot clinical trials with human subjects are allowable.
• Required Pre-Application Deadline: May 27, 2021
• Application Submission Deadline: September 10, 2021
Areas of Interest
All applications submitted to this program announcement must address one of the following FY21 PRORP CTRA 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 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. a. 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. b. 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. Tissue Regeneration Therapeutics: Advanced tissue regeneration therapeutics in nerve, muscle, and/or composite tissue for the restoration of traumatically injured extremities. Isolated bone or cartilage tissue engineering studies are excluded. Early clinical feasibility studies involving volumetric muscle loss are encouraged.
3. Compartment Syndrome: Novel treatment strategies to improve current diagnoses for compartment syndrome. Alternatives to intracompartmental pressure measurements are encouraged.
4. Osseointegration: Identification of best practices to address infection, rejection, and/or failure of percutaneous osseointegrated prosthetic limbs.
5. Prosthetic and Orthotic Devices: 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, and impairment. Multicenter studies that focus on transfemoral amputees are encouraged.
Independent investigators at all academic levels (or equivalent) may be named by the organization as the PI on the application. There are no limitations 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.
The anticipated total costs budgeted for the entire period of performance for an FY21 PRORP CTRA will not exceed $1.5M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.