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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07263945
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 25, 2025
Status verified
Apr 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado, Anschutz Medical CampusAuroraColorado80045-2559
Natalie Harpenau, M.S
[email protected]
‪(720) 772-6887
Brecca Gaffney, PhD
[email protected]
303-315-7559
Brecca Gaffney, PhD (PRINCIPAL_INVESTIGATOR)
Jason Stoneback, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado, Anschutz Medical Campus· Aurora, CO

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