Home › NCT07263945
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Unilateral transtibial amputation due to traumatic, congenital, or cancer-related causes * \> 12-months bone-anchored limb implantation surgery (Bone Anchored Limb group) * \> 12-months limb amputation (Socket Control group) * Non-vascular amputation etiology * Low profile prosthetic foot (nominal) * Can walk unassisted for 5-minutes * \> 18 years old Exclusion Criteria: * Major amputation on contralateral limb * Vascular amputation etiology * Neurologic pathology that impairs coordination/balance * Regular assistive device use required for community ambulation * Inflammatory diseases or diabetes * Pregnancy or breastfeeding
About the study
A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.
What is being tested
- As-prescribed prosthetic foot stiffness (device)
- A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot (device)
- A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot (device)
Sponsor: University of Colorado, Denver · Participants: 60 · Started: Nov 25, 2025
Contact the study team
- Brecca Gaffney, PhD · Phone: 303-315-7559
- Natalie Harpenau, MS · Phone: (720) 772-6887
Official record on ClinicalTrials.gov — NCT07263945
Locations in the U.S.
| Colorado | University of Colorado, Anschutz Medical Campus, Aurora |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.