DOD, Orthotics and Prosthetics Outcomes Clinical Trial Award | HT9425 23 OPORP CTA

Opportunity Information: Apply for HT9425 23 OPORP CTA

The Department of Defense (DoD) Orthotics and Prosthetics Outcomes Clinical Trial Award (FY23 OPORP CTA; Funding Opportunity Number HT9425 23 OPORP CTA) is a research funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) that focuses on quickly launching clinical trials that can meaningfully improve care and quality of life for people with limb loss or limb impairment. The target impact population includes Service Members and military beneficiaries, Veterans, and civilians who rely on orthotic or prosthetic devices. The central goal is to produce clinically useful, patient-centered evidence that helps clinicians, health systems, and policymakers make better decisions about which orthoses and prostheses work best, for whom, and under what real-world conditions.

Projects funded under this mechanism must be clinical trials evaluating orthoses and/or prostheses, and they are expected to use patient-centric outcomes rather than purely technical or laboratory endpoints. In other words, the program is looking for evidence that translates into day-to-day benefits such as function, mobility, comfort, participation, pain, skin health, fatigue, satisfaction, or other outcomes that matter to users and their providers. The scope is intentionally broad: proposals can range from smaller proof-of-concept or feasibility trials (designed to test whether an approach is workable and to guide the design of later studies) to larger, more definitive trials conducted in relevant patient populations. The announcement also signals strong interest in alternative trial designs that make results easier to adopt in routine practice, including pragmatic trials and practice-based evidence studies, especially when they can inform real-world clinical decisions or policy decisions about coverage, standards of care, or implementation.

A notable emphasis in the program is on multidisciplinary approaches, particularly those that address secondary injuries associated with limb loss or impairment. This can include strategies aimed at reducing downstream harms such as overuse injuries, joint degeneration, falls, skin breakdown, or other complications that emerge with long-term device use and compensatory movement patterns. If a study includes rehabilitation strategies (for example, a therapy protocol paired with a device), the application must clearly explain how the rehabilitation approach is expected to improve outcomes related to the orthotic or prosthetic device compared to standard of care. The program encourages collaboration across sectors, including academia, industry, patient advocacy groups, military Services, the Department of Veterans Affairs (VA), and other federal agencies, but collaboration is not a strict requirement.

The FY23 OPORP CTA is organized into two distinct research levels, and applicants must choose only one level per application. Research Level 1 is meant for pilot and early-stage clinical trials that are exploratory and involve limited human exposure, commonly reflected by smaller sample sizes. Even though these are early trials, they must still have a clear path toward clinical translation and the potential for meaningful advancement in the field. Importantly, Level 1 requires preliminary data, which may be published or unpublished. Research Level 2 is intended for larger, more definitive clinical trials with enough statistical power and participant numbers to support robust conclusions that could shape evidence-based practice and potentially change clinical care. The solicitation explicitly welcomes designs such as pragmatic clinical studies, randomized controlled trials, and comparative effectiveness studies. For Level 2, published preliminary data relevant to the proposed trial are required, while unpublished data can be included as additional support for the rationale.

This opportunity is open to a wide range of applicant organizations (eligibility is listed as unrestricted, subject to any clarifications in the full announcement). Awards may be made as grants or cooperative agreements, and the activity is categorized under research and development (CFDA 12.420). The posting date in the source information is April 27, 2023, with an original closing date of July 12, 2023, and the program anticipated making about four awards. The award ceiling is listed as 0 in the provided source data, which typically indicates that the maximum funding amount is not specified in that field and applicants need to consult the full funding announcement for budget constraints and level-specific limits. Finally, the program is strictly clinical in nature for humans: preclinical animal studies are not supported under this announcement.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD, Orthotics and Prosthetics Outcomes Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Apr 27, 2023.
• Applicants must submit their applications by Jul 12, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 4 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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