Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: As-prescribed prosthetic foot stiffness, A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot, A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot.
- Who it may be relevant to
- Registry conditions: Amputation, Transtibial Amputation - Unilateral, Bone Anchored Devices, Osseointegration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This will be a clinical trial with two groups (individuals with a unilateral transtibial amputation using either an osseointegrated bone-anchored limb or socket prosthesis that will implement a cross-over design. The objective of this clinical trial is to determine how changes in prosthetic foot stiffness influence clinical and biomechanical outcomes in patients with transtibial osseointegrated bone-anchored limbs compared to patients with transtibial amputation using a standard socket-suspended prosthesis. Although proper loading between the bone and implant is pivotal to promote and maintain osseointegration, which is required for physiological loading and thus positive outcomes, evidence surrounding the role of how prosthetic componentry influences force transmission and functional outcomes in this population currently does not exist. The findings of this clinical trial will address a critical knowledge gap pertaining to the role of componentry on multi-loading domain outcomes. Outcomes will be assessed in each participant in the same three conditions: one with their clinical prescribed prosthetic foot, one with a soft prosthetic foot (-2 stiffness categories less than prescribed), and one with a stiff prosthetic foot (+2 stiffness categories more than prescribed). This data will be used to test/develop the following aims: 1) Does foot stiffness change loading between the bone and implant during activities of daily living? 2) Does foot stiffness influence measures of function, pain, and biomechanics in patients with transtibial osseointegrated bone-anchored limbs differently than a socket prosthesis? 3) Does foot stiffness influence sensitivity, balance, and fall risk in patients using an osseointegrated bone-anchored limb different than a socket prosthesis? and 4) (exploratory) develop an optimization platform using computer models to determine the optimal foot stiffness that maximizes joint loading symmetry and minimizes metabolic cost.
Interventions
- Device As-prescribed prosthetic foot stiffness
Each participant will complete a motion capture collection, tests of physical function, and sensory tests in their currently prescribed prosthetic foot. - Device A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot
Each participant will complete a motion capture collection, tests of physical function, and sensory tests in a prosthetic foot that is two categories stiffer than their currently prescribed prosthetic foot. - Device A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot
Each participant will complete a motion capture collection, tests of physical function, and sensory tests in a prosthetic foot that is two categories softer than their currently prescribed prosthetic foot.
Primary outcome measures
- Bone-Implant Stress/Strain Impulse during Decline Walking (internal) [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
Secondary outcome measures (12)
- Bone-Implant Dynamic Stress/Strain Impulse (internal) [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Bone Dynamic Stress/Strain Impulse (internal) [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Implant Dynamic Stress/Strain Impulse (internal) [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Prosthesis Force Impulse (external abutment) [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Sensory Threshold [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Postural Sway [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Reactive Postural Control Time [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Whole-Body Angular Momentum [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Self-Selected Gait Speed [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- L-Test Time [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Acceptability of Intervention Measure [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
- Prosthetic Limb Users Survey of Mobility [Time frame: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Colorado, Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT07263945 · 25-0854 · 1R01HD119003-01