Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Recruiting now · Phase 1
Conditions studied: Amputation, Transtibial Amputation - Unilateral, Bone Anchored Devices, Osseointegration
In brief
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 facts
- Study ID
- NCT07263945
- Run by
- University of Colorado, Denver
- People needed
- 60
- Starts
- 2025-11-25
- Expected to finish
- 2030-05-31
- Last updated by the study team
- 2026-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of Colorado, Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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