Hanger Clinic is Part of Research Team Awarded DoD Grant for Largest Clinical Trial of Its Kind

Hanger Clinic’s Department of Clinical and Scientific Affairs is among a prestigious group of researchers awarded a nearly $2,000,000 grant from the Department of Defense (DoD) to study fall-related health outcomes in lower limb prosthesis users, including the largest clinical trial of microprocessor-controlled knees (MPKs) to-date.

The project, part of the DoD’s Congressionally Directed Medical Research Programs’ Orthotics and Prosthetics Outcomes Research Program, is scheduled to begin Sept. 30, 2020 and will be led by Brian Hafner, PhD (University of Washington). Hanger Clinic’s Director of Clinical Research, Shane Wurdeman, PhD, CP, joins Andrew Sawers, PhD, CPO (University of Illinois at Chicago) and Sara Koehler-McNicholas, PhD (Minneapolis Veterans Administration Health Care System) as site leads for this ambitious project.

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Project Overview

The first two aims of the project will develop and validate new outcome measures to better assess the impact of falls on individuals who use a lower limb prosthesis. The instruments designed and tested during the first two aims will be applied in aim three, a pragmatic, randomized, clinical trial to be conducted at Hanger Clinic.

The clinical trial, expected to be the largest of its kind to-date, will enroll 100 K2-level above-knee amputees from Hanger Clinic. Half will be randomized into an MPK, while the other half will be randomized to a non-MPK which is the current standard for this K-level.

Evidence from smaller-scale studies suggests that this population could benefit from MPK technology; however, the level of evidence has not yet been sufficient to support coverage policies that would allow K2 level individuals access to this type of technology.