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

NCT07263945 | Recruiting Phase 1

• 2 other identifiers: 25-08541R01HD119003-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

amputation; bone anchored limb; osseointegration; transtibial amputation; below knee amputation; prosthetics

Outcome Measures

Primary Outcomes (1)

• Bone-Implant Stress/Strain Impulse during Decline Walking (internal)

  Stress/strain impulse at the bone-implant interface (area under time series curve) will be calculated during the stance period of the decline walk (-5 degrees). Subject-specific finite element models will be developed for each bone-anchored limb participant to calculate this outcome. This will be done by including each participant's movement patterns, muscle forces, joint forces, bone geometry and bone health. Movement patterns, muscle forces, and joint loading will be calculated from musculoskeletal modeling using whole-body motion data collected from 70 wearable reflective markers (Vicon, Centennial, CO), ground reaction forces simultaneously collected from an instrumented treadmill (Bertec, Columbus, OH). Bone geometry and healthy will be determined from quantitative computed tomography bone scans.

  Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks

Secondary Outcomes (14)

• Bone-Implant Dynamic Stress/Strain Impulse (internal)

  Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks

• Bone Dynamic Stress/Strain Impulse (internal)

  Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks

• Implant Dynamic Stress/Strain Impulse (internal)

  Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks

• Prosthesis Force Impulse (external abutment)

  Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks

• Sensory Threshold

  Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks

Study Arms (3)

Two prosthetic foot stiffness categories stiffer than the as-prescribed prosthetic foot stiffness

ACTIVE COMPARATOR

A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal (as-currently prescribed) foot.

Device: A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot

Two prosthetic foot stiffness categories softer than the as-prescribed prosthetic foot stiffness

ACTIVE COMPARATOR

A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal foot.

Device: A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot

As-prescribed prosthetic foot stiffness

ACTIVE COMPARATOR

The prosthetic foot that is currently prescribed and used by each participant daily.

Device: As-prescribed prosthetic foot stiffness

Interventions

As-prescribed prosthetic foot stiffness DEVICE

Each participant will complete a motion capture collection, tests of physical function, and sensory tests in their currently prescribed prosthetic foot.

As-prescribed prosthetic foot stiffness

A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot DEVICE

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.

Two prosthetic foot stiffness categories stiffer than the as-prescribed prosthetic foot stiffness

A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot DEVICE

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.

Two prosthetic foot stiffness categories softer than the as-prescribed prosthetic foot stiffness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045-2559, United States

RECRUITING

Central Study Contacts

Brecca Gaffney, PhD

CONTACT

303-315-7559; BRECCA.GAFFNEY@UCDENVER.EDU

Eliza Biondi, MS

CONTACT

eliza.biondi@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: December 4, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The investigators will publish the trial results within one year of testing the final participant.
• Access Criteria: User registration will be required to access/download any data and will require agreement to conditions of use in accordance with CDMRP Policy on Sharing Data and Research Resources.

Locations

US (1)