Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVO… (NCT06627361) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot.
France30 participantsStarted 2023-11-22
Plain-language summary
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:
1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase.
2. The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase.
3. An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot.
The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.
Who can participate
Age range
18 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:
Adult patient (over 18 years of age)
* Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot.
* Regularly using (more than 8 hours/day) a class III ESAR foot
* Functional class (CNEDiMTS indication)1
* Insured person.
* Able to answer questionnaires.
* Providing informed and written consent to participate in the study.
* Having a normalized PLUS-M/FC 12 score less than 50 for vascular amputee and 55 for traumatic amputee and other causes of amputation.
* Experiencing no discomfort related to the socket indicated by a score ≥ 6 on the numerical scale from 0 to 10 (Socket Comfort Score)
Exclusion Criteria:
* Bilateral lower limb amputation
* Femoral amputation
* Wearing a temporary prosthesis
* Change of socket or suspension system planned during the study.
* Change of any functional component as torsion or choc adapter
* Significant change in the patient's routine activities expected during the study.
* Progressive associated pathology that may prevent patient follow-up.
* Associated pathology that may limit the patient's mobility (e.g. disarticulation of the knee, knee pain... )
* No osteointegration patients
* Lack of consent
* Adult subject to enhanced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.
* Person not affiliated with or a beneficiary of a health insurance plan.
* Patient unable…
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.