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New treatment option for Amputation
Official title Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
ClinicalTrials.gov ID: NCT07263945
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.