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NCT07263945 · ClinicalTrials.gov registry record · Phase 1
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
A Phase 1 study of Amputation and Osseointegration, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07263945: Recruiting Phase 1 study of Amputation and Osseointegration, sponsored by University of Colorado, Denver.
NCT07263945 is a Phase 1 study of Amputation and Osseointegration that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 60 participants, below the 132-participant average among 65 other Amputation trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07263945, a Phase 1 study of Amputation and Osseointegration, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Stress/strain impulse at the bone-implant interface (area under time series curve) will be calculated during the stance period of the decline walk (-5 degrees). Subject-specific finite element models will be developed for each bone-anchored limb participant to calculate this outcome. This will be done by including each participant's movement patterns, muscle forces, joint forces, bone geometry and bone health. Movement patterns, muscle forces, and joint loading will be calculated from musculoske
Conditions Studied
Interventions
- DEVICE As-prescribed prosthetic foot stiffness
- DEVICE A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot
- DEVICE A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot
Study Locations (1)
Colorado
- University of Colorado, Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-11-25 |
| Est. Completion | 2030-05-31 |
| Phase | Phase 1 |
What NCT07263945 shows while recruiting
NCT07263945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 132-participant average among 65 other Amputation trials with a reported enrollment target (55% lower).
The record links to 4 conditions, with Amputation appearing as the primary indexed condition, and to 3 interventions - of which As-prescribed prosthetic foot stiffness is the first listed.
NCT07263945 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT07263945 about?
NCT07263945 is a clinical study titled "Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes". 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) ...
What is the current status of trial NCT07263945?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-11-25. Estimated completion is 2030-05-31.
What conditions does trial NCT07263945 study?
This clinical trial studies the following conditions: Amputation, Osseointegration, Transtibial Amputation - Unilateral, Bone Anchored Devices.
What interventions are being tested in trial NCT07263945?
The interventions under investigation include: As-prescribed prosthetic foot stiffness (DEVICE), A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot (DEVICE), A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot (DEVICE).
Who is sponsoring clinical trial NCT07263945?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07263945 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07263945's enrollment target sits among peer trials
60 14th of 65 higher than 51 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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