The goal of this clinical trial is to determine how changes in prosthetic foot stiffness influence various biomechanical outcomes in individuals with a below-knee amputation using either an osseointegrated bone-anchored limb or a standard socket prosthesis.
The University of Colorado Bone-Anchored Limb Research Group is conducting a research study to determine the influence of prosthetic foot stiffness in below-knee osseointegrated bone-anchored limb users compared to traditional socket-based prostheses. Osseointegrated bone-anchored limbs are a promising alternative to socket prostheses for those who suffer from chronic socket-related problems by directly attaching the prosthetic limb to the body through a bone-anchored implant. It is known from evidence in socket users that the stiffness of the prosthetic foot influences many factors including limb-loading, balance, perception, energy expenditure. However, no such evidence exists specific to osseointegrated bone-anchored limbs. Although proper limb-loading during every day activities is important for positive health outcomes, there is no evidence existing surrounding how changes in prosthetic foot stiffness may influence biomechanics differently between osseointegrated bone-anchored limbs and socket-based prostheses. This clinical trial, supported by the National Institutes of Health, will be the first to provide evidence used to better inform how prosthetic feet should be prescribed specific to prosthesis type.
You may join the study if you: -Are between 18 and 80 years old -Have a below-knee amputation on one limb -Use either a socket-suspended prosthesis or osseointegrated bone-anchored limb -Are at least 1-year post amputation surgery or bone-anchored limb implantation surgery -Can walk unassisted for 5-minutes -Do not have any neurologic, musculoskeletal, inflammatory diseases -Are not currently pregnant or breast feeding More information is available at ClinicalTrials.gov
Protocol Number: 25-0854
Brecca Gaffney
Principal Investigator