How prosthetic foot stiffness affects outcomes after a below-knee amputation with bone-anchored or socket prostheses
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT07263945 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.