Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes (NCT07263945) | Clinical Trial Compass
RecruitingPhase 1
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
United States60 participantsStarted 2025-11-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone-Implant Stress/Strain Impulse during Decline Walking (internal)
Timeframe: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks