DoD Orthotics and Prosthetics Outcomes, Clinical Trial Award | W81XWH 22 OPORP CTA

Opportunity Information: Apply for W81XWH 22 OPORP CTA

The DoD Orthotics and Prosthetics Outcomes, Clinical Trial Award (FY22 OPORP CTA) is a Department of Defense funding opportunity designed to speed up the launch and execution of clinical trials that can meaningfully improve health, function, and overall quality of life for people living with limb loss or limb impairment. The program is especially focused on populations connected to military service, including Service Members, military beneficiaries, and Veterans, while also allowing relevance to civilians with similar clinical needs. At its core, the award supports trials that test orthotic and/or prosthetic devices using patient-centric outcomes, meaning the evidence generated should reflect what actually matters to patients in day-to-day life (for example mobility, comfort, pain, participation in work and community life, independence, durability, and other real-world measures). The intention is to produce clinically useful evidence that can directly guide care decisions and ultimately optimize outcomes for people who use these devices.

The scope is deliberately broad in terms of trial maturity. Applicants can propose smaller, proof-of-concept studies meant to show feasibility, refine protocols, or generate effect-size estimates that inform a future larger trial. At the same time, the opportunity also welcomes large, definitive clinical trials in relevant patient populations when the supporting foundation is strong enough to justify that scale. The program explicitly encourages alternative clinical research approaches beyond traditional tightly controlled studies, particularly pragmatic trials and practice-based evidence studies. These designs are valued because they test devices in conditions closer to routine clinical practice, producing evidence that is more immediately usable for adoption decisions, clinical guidelines, payer considerations, and policy choices.

Another priority area embedded in the announcement is secondary injury prevention and mitigation, recognizing that limb loss or impairment can lead to downstream complications such as overuse injuries, falls, joint degeneration, skin breakdown, back pain, and other musculoskeletal problems. The program is interested in multidisciplinary efforts that bring together the expertise needed to address these issues comprehensively, which could involve clinicians, engineers, rehabilitation specialists, outcomes researchers, statisticians, and policy or implementation experts. If a proposal includes rehabilitation strategies (either as the main intervention or as a key component), the application needs to clearly explain how that rehabilitation approach is expected to improve orthotic or prosthetic device outcomes compared to the current standard of care, rather than treating rehabilitation as a generic add-on.

Funding is organized into two distinct levels, and an applicant must choose only one level per application. Funding Level 1 is intended for pilot and early-stage clinical trials that are exploratory, involve limited human exposure (often meaning smaller sample sizes), and are positioned to make meaningful progress toward clinical translation even at a preliminary stage. This level still requires preliminary data, and the solicitation allows that evidence to be either published or unpublished. Funding Level 2 is meant for larger clinical trials that can substantially advance clinical translation and potentially shift evidence-based practice. These projects are expected to have robust designs and statistically meaningful participant numbers that can provide definitive support for clinical decision-making. The program welcomes and encourages pragmatic clinical studies, randomized controlled trials, and comparative effectiveness research at this level. For Funding Level 2, published preliminary data relevant to the proposed trial are required, with unpublished data allowed as additional support to strengthen the rationale.

From an administrative standpoint, this opportunity is run by the Department of Defense (Department of the Army, USAMRAA) under CFDA 12.420, and it is offered as either a grant or a cooperative agreement depending on project needs and the level of involvement anticipated from the funding agency. Eligibility is listed as unrestricted, meaning it is open to a wide range of organization types, subject to any specific eligibility clarifications in the full announcement. The FY22 posting indicated an anticipated total of about five awards. The public listing showed an award ceiling of 0, which typically signals that applicants must rely on the detailed funding restrictions section in the full solicitation for actual budget limits by funding level rather than using a single posted cap. The opportunity was originally posted on March 22, 2022, with an original closing date of June 1, 2022.

• 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 Mar 22, 2022.
• Applicants must submit their applications by Jun 01, 2022. (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 5 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.

Apply for W81XWH 22 OPORP CTA

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