Hanger, Austin, Texas, will be part of a research group funded by 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 grant amounts to nearly $2,000,000.
The funds, supporting Hanger Clinic’s Department of Clinical and Scientific Affairs, the University of Washington (UW), the University of Illinois at Chicago (UIC), and the Minneapolis Veterans Administration Health Care System (MVAHCS), are part of the DOD’s Congressionally Directed Medical Research Programs’ Orthotics and Prosthetics Outcomes Research Program.
The project, scheduled to begin September 30, will be led by Brian Hafner, PhD (UW); Shane Wurdeman, PhD, CP, Hanger Clinic’s director of clinical research; Andrew Sawers, PhD, CPO (UIC); and Sara Koehler-McNicholas, PhD (MVAHCS), as site leads.
The research goals are to develop and validate new outcome measures to better assess the impact of falls on individuals who use a lower-limb prosthesis and to conduct a pragmatic, randomized clinical trial at Hanger Clinic.
“There is a growing body of evidence strongly suggesting patient benefits of MPKs for limited, community ambulators, or K2-level ambulators,” said Wurdeman. “The ability to study this technology in a controlled trial of this scale will significantly further our understanding of the potential benefits for these individuals.”
The clinical trial, expected to be the largest of its kind to date, will enroll 100 Hanger Clinic patients who have transfemoral amputations and are categorized at a K2 activity level. Half will be randomized into an MPK, while the other half will be randomized to a non-MPK, which is the current K2 standard. 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 individuals with a K2-level access to this type of technology.
“This project supports the Orthotics and Prosthetics Outcomes Research Program’s mission by advancing orthotic and prosthetic research to optimize evidence-based care and clinical outcomes for military-related neuromusculoskeletal injury,” said Tracy Behrsing, PhD, health science program manager for the program.