DOD, Orthotics and Prosthetics Outcomes Clinical Trial Award

The FY23 OPORP CTA is intended to support the rapid implementation of clinical trials with the potential to have a significant impact on improving the health and well-being of Service Members and military beneficiaries, Veterans, and other individuals with limb loss and/or limb impairment. This award mechanism 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. Proposed projects may range from small proof-of-concept trials to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials in relevant patient populations. 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. The FY23 OPORP is also interested in multidisciplinary projects that address strategies to mitigate secondary injuries. Studies proposing or evaluating rehabilitation strategies must indicate how the rehabilitation may improve the orthotic or prosthetic device outcome when compared to standard of care.

Applications involving multidisciplinary collaboration among academia, industry, patient advocacy, the military Services, the U.S. Department of Veterans Affairs (VA), and/or other federal government agencies are encouraged but not required.

The FY23 OPORP CTA offers funding for two Research Levels (Refer to Section II.D.5, Funding Restrictions). Only one Research Level category may be chosen per application, and the choice of application category is at the discretion of the applicant. The following are generalized descriptions of the scope of research appropriate for each Research Level:

• Research Level 1 supports pilot and early-stage clinical trials that are exploratory and involve limited human exposure (e.g., small sample size), with the potential to make significant advancements toward clinical translation. Preliminary data, published or unpublished, are required.

• Research Level 2 supports large clinical trials that have the potential to make significant advancement toward clinical translation. Proposed projects may include large-scale trials that, if successful, will produce high-quality outcomes with robust, statistically relevant participant numbers to provide strong, definitive support for evidence-based practice and/or have the potential to drive changes in clinical practice. Pragmatic clinical studies, randomized controlled trials, and comparative effectiveness studies are welcome and encouraged. Published preliminary data relevant to the proposed clinical trial are required. Unpublished preliminary data may be included to further support the study rationale.

Preclinical studies using animals are not supported by this program announcement.