NCT07263945

Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This will be a clinical trial with two groups (individuals with a unilateral transtibial amputation using either an osseointegrated bone-anchored limb or socket prosthesis that will implement a cross-over design. The objective of this clinical trial is to determine how changes in prosthetic foot stiffness influence clinical and biomechanical outcomes in patients with transtibial osseointegrated bone-anchored limbs compared to patients with transtibial amputation using a standard socket-suspended prosthesis. Although proper loading between the bone and implant is pivotal to promote and maintain osseointegration, which is required for physiological loading and thus positive outcomes, evidence surrounding the role of how prosthetic componentry influences force transmission and functional outcomes in this population currently does not exist. The findings of this clinical trial will address a critical knowledge gap pertaining to the role of componentry on multi-loading domain outcomes. Outcomes will be assessed in each participant in the same three conditions: one with their clinical prescribed prosthetic foot, one with a soft prosthetic foot (-2 stiffness categories less than prescribed), and one with a stiff prosthetic foot (+2 stiffness categories more than prescribed). This data will be used to test/develop the following aims: 1) Does foot stiffness change loading between the bone and implant during activities of daily living? 2) Does foot stiffness influence measures of function, pain, and biomechanics in patients with transtibial osseointegrated bone-anchored limbs differently than a socket prosthesis? 3) Does foot stiffness influence sensitivity, balance, and fall risk in patients using an osseointegrated bone-anchored limb different than a socket prosthesis? and 4) (exploratory) develop an optimization platform using computer models to determine the optimal foot stiffness that maximizes joint loading symmetry and minimizes metabolic cost.

Conditions

• Amputation
• Transtibial Amputation - Unilateral
• Bone Anchored Devices
• Osseointegration

Interventions

Type	Name	Description
DEVICE	As-prescribed prosthetic foot stiffness	Each participant will complete a motion capture collection, tests of physical function, and sensory tests in their currently prescribed prosthetic foot.
DEVICE	A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot	Each participant will complete a motion capture collection, tests of physical function, and sensory tests in a prosthetic foot that is two categories stiffer than their currently prescribed prosthetic foot.
DEVICE	A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot	Each participant will complete a motion capture collection, tests of physical function, and sensory tests in a prosthetic foot that is two categories softer than their currently prescribed prosthetic foot.

Timeline

• Start date: 2025-11-25
• Primary completion: 2030-05-31
• Completion: 2030-05-31
• First posted: 2025-12-04
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States