How prosthetic foot stiffness affects outcomes after a below-knee amputation with bone-anchored or socket prostheses
Official title: Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Run by University of Colorado, Denver · NCT07263945 · Data updated 2026-11-12
This trial will test whether using a softer, your usual, or a stiffer prosthetic foot changes comfort, walking function, and bone‑implant loading for adults with a single below‑knee amputation who use either a bone‑anchored limb or a socket prosthesis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | November 25, 2025 |
| Main results expected | May 31, 2030 |
| Study ends | May 31, 2030 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07263945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with a unilateral transtibial amputation from nonvascular causes who can walk unassisted for 5 minutes and are at least 12 months post‑amputation (or ≥12 months after osseointegration surgery for the bone‑anchored group) using a low‑profile prosthetic foot.
✕Probably not a fit
People with vascular‑cause amputations, major contralateral amputation, neurologic balance disorders, regular need for assistive devices for community ambulation, inflammatory disease or diabetes, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a crossover interventional trial comparing people with unilateral transtibial amputation who use osseointegrated bone‑anchored limbs versus those who use standard socket prostheses. Each participant will complete walking and daily‑living tasks with three foot conditions: their prescribed foot, a foot two stiffness categories softer, and a foot two categories stiffer. Outcomes include dynamic bone‑implant loading, multi‑joint biomechanics, function and pain measures, osseoperception, and fall risk. Results will be used to identify target ranges of foot stiffness that produce optimal biomechanical and clinical outcomes.
Why it matters
Potential benefit: If successful, identifying optimal foot stiffness could improve comfort and function, reduce harmful bone‑implant loading, and lower fall risk for people with below‑knee osseointegrated limbs.
How similar studies have gone: Some prior work has examined foot stiffness effects in socket prosthesis users, but there is little prior evidence specifically addressing how foot stiffness affects outcomes in osseointegrated bone‑anchored limbs, making this approach relatively novel for that population.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States Recruiting
Study contacts
- Study coordinator: Brecca Gaffney, PhD
- Email: BRECCA.GAFFNEY@UCDENVER.EDU
- Phone: 303-315-7559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.