Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Recruiting
Phase 1
Interventional Study
Amputation
Transtibial Amputation - Unilateral
Bone Anchored Devices
Osseointegration
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 60 (estimated)
- Sponsor
- University of Colorado, Denver · Other
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About This Trial
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 h…
Trial Locations
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Eligibility 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 pro…
Contacts