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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, Veterans and all patients with orthopaedic injuries.
- One goal of the FY22 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 FY22 PRORP CTRA differs from the FY22 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.
• Required Pre-Application Deadline: June 16, 2022
• Application Submission Deadline: September 13, 2022
Areas of Interest
In September 2021, the PRORP hosted a stakeholders meeting to identify critical knowledge and capability gaps in orthopaedic research and care. Representatives from non-profit organizations, academia, industry, government institutions, and the public shared broad perspectives on potential barriers in research and patient outcomes, key knowledge and scientific gaps, and potential approaches for addressing orthopaedic needs. Resources shared during the meeting and outcomes of the effort can be found on the CDMRP website (https://cdmrp.army.mil/ prorp/default). The FY22 PRORP Focus Areas incorporate several of the stakeholder-identified gaps.
Applications submitted to this program announcement must address one of the following FY22 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 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.
- 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. Development of novel nerve, soft tissue, muscle, and/or skeletal diagnostic capabilities at the point of injury (near battlefield) for diagnosis of underlying pathology and efficacy of interventions. 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. 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 and/or Reperfusion Injury: Novel treatment strategies to improve current diagnoses for compartment syndrome and/or reperfusion injury. Proposals that address the novel treatment strategies to improve the management of reperfusion injury will be considered. 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. 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, and impairment. Multicenter studies that focus on transfemoral amputees are encouraged as are advanced limb orthoses that span at least one major joint (i.e., ankle, knee, and elbow).
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 FY22 PRORP Clinical Translational Research Award will not exceed $1.5M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.