Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Major amputation on contralateral limb
Vascular amputation etiology
Neurologic pathology that impairs coordination/balance
Regular assistive device use required for community ambulation
Trial design
Design model
Crossover
Treatments tested in this trial
As-prescribed prosthetic foot stiffness
DeviceEach participant will complete a motion capture collection, tests of physical function, and sensory tests in their currently prescribed prosthetic foot.
A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot
DeviceEach 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.
A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot
DeviceEach 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Two prosthetic foot stiffness categories stiffer than the as-prescribed prosthetic foot stiffnessActive comparator 1 intervention
Group B: Two prosthetic foot stiffness categories softer than the as-prescribed prosthetic foot stiffnessActive comparator 1 intervention
Group C: As-prescribed prosthetic foot stiffnessActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bone-Implant Stress/Strain Impulse during Decline Walking (internal)
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 musculoskeletal modeling using whole-body motion data collected from 70 wearable reflective markers (Vicon, Centennial, CO), ground reaction forces simultaneously collected from an instrumented treadmill (Bertec, Columbus, OH). Bone geometry and healthy will be determined from quantitative computed tomography bone scans.
Time frame
Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeksSecondary outcomes
1
Bone-Implant Dynamic Stress/Strain Impulse (internal)
Stress/strain impulse at the bone-implant interface (area under time series curve) will be calculated for each bone-anchored limb participant using motion and force data collected during the stance period of treadmill walking at level and incline (+5 degree) angles.
Time frame
Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks2
Bone Dynamic Stress/Strain Impulse (internal)
Stress/strain impulse for the amputated tibia bone (area under time series curve) will be calculated for each bone-anchored limb participant using motion and force data collected during the stance period of treadmill walking at level, incline (+5 degree), and decline (-5 degree) angles.
Time frame
Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks3
Implant Dynamic Stress/Strain Impulse (internal)
Stress impulse for the prosthesis implant (area under time series curve) will be calculated for each bone-anchored limb participant using motion and force data collected during the stance period of treadmill walking at level, incline (+5 degree), and decline (-5 degree) angles.
Time frame
Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks4
Prosthesis Force Impulse (external abutment)
Force impulse in the vertical direction (area under the time series curve) will be calculated for all study participants using motion and force data collected from the triaxial load sensor in the prosthesis (iPECSTM) during the stance period of treadmill walking at level, incline (+5 degree), and decline (-5 degree) angles.
Time frame
Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov