DoD Orthotics and Prosthetics Outcomes Research Program, Clinical Trial Award

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The FY19 OPORP CTA is intended to support clinical trials that evaluate orthotic and/or prosthetic devices using patient-centric outcomes relevant to Service members and Veterans with limb loss and/or limb impairment. The funding opportunity challenges the scientific community to address which orthotic and prosthetic devices, and which characteristics of those devices, generate the best patient outcomes. The FY19 OPORP CTA is focused on outcomes-based best practices through analysis of prosthetic and/or orthotic device options that are currently available, and not on the development of a new technology or the improvement of an existing technology. Outcomes-focused research is used to support evidence-based practice, which guides providers in the optimization of care to those with limb loss and/or limb impairment. Applications involving multidisciplinary collaborations among academia, industry, the military Services, the Department of Veterans Affairs (VA), and other Federal Government agencies are highly encouraged. The FY19 OPORP CTA supports the rapid 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 deficit. Alternate research designs (e.g., pragmatic and practice-based evidence trials) that provide evidence for adoption of tested orthotic and/or prosthetic devices in real-world clinical practice and inform clinical or policy decisions are particularly encouraged. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, Phase 0) to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.

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