Recruiting

Phase 1

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

Sponsor:

University of Colorado, Denver

Code:

NCT07263945

Conditions

Amputation

Transtibial Amputation - Unilateral

Bone Anchored Devices

Osseointegration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Transtibial Amputation - Unilateral

Bone Anchored Devices

Osseointegration

Study ID

NCT07263945

Start date

Nov 25, 2025

Status verified date

Apr, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: 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. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal (as-currently prescribed) foot.

active comparator: Two prosthetic foot stiffness categories softer than the 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. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal foot.

active comparator: As-prescribed prosthetic foot stiffness

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

Interventions

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.

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.

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.

Primary outcome measure

Bone-Implant Stress/Strain Impulse during Decline Walking (internal) [ Time Frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks ]

Central Contacts and Locations

Central contacts

Brecca Gaffney, PhD

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

Natalie Harpenau, MS

‪(720) 772-6887 NATALIE.HARPENAU@CUANSCHUTZ.EDU

Locations

University of Colorado, Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045-2559

Contacts

Natalie Harpenau, M.S

‪(720) 772-6887 NATALIE.HARPENAU@CUANSCHUTZ.EDU

Brecca Gaffney, PhD

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

Principal Investigator:

Brecca Gaffney, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

amputation
bone anchored limb
osseointegration
transtibial amputation
below knee amputation
prosthetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-04-21.