An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission
United States2 participantsStarted 2017-04-15
Plain-language summary
The purpose of the study is to investigate the clinical and functional outcomes of a transfemoral amputation with osseointegrated titanium implant, AMI muscle constructs, and implanted electrodes in the domain of gait, free space control, and embodiment.
Who can participate
Age range
22 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1 Male or Female age 22-65 at the time of surgery.
* 2 The patient must have a medical condition requiring performance of a unilateral transfemoral amputation with a minimum of 13 cm of residual femur after amputation, and: A. At a minimum level of amputation of 20 cm or greater above the knee joint line if physical therapy and prosthetist evaluation is commensurate with a standard K3 ambulatory status; or, B. At a minimum level of amputation of 16 cm above the knee joint line as part of a single- stage procedure if physical therapy and prosthetist evaluation is commensurate with a more active K3 or less active K4 postoperative ambulatory status.
* The subject must have undergone independent consultation with at least two lower extremity surgical specialists to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition.
* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
* The patient must have adequate bone stock to support the implanted device.
* In the opinion of the investigators, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/or study candidate.
* Willingness, ability and commitment to participate in baseline and follow-up evaluat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Kinematic Measures of Lower-Limb Biomechanics
Timeframe: An average of 2 sessions in the span of 1 week
2
Spatiotemporal Gait Parameters
Timeframe: An average of 2 sessions in the span of 1 week
3
Assessment of Patient Ability to Control each Joint of the Prosthesis
Timeframe: An average of 2 sessions in the span of 1 week
4
Ground Reaction Forces
Timeframe: An average of 2 sessions in the span of 1 week
5
Joint Torques
Timeframe: An average of 2 sessions in the span of 1 week
6
Walking speed
Timeframe: An average of 2 sessions in the span of 1 week