Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM) (NCT06522646) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
France12 participantsStarted 2018-07-09
Plain-language summary
The main aim of this study is to compare the adaptation capabilities of the microprocessor-controlled knee-ankle prosthesis system with the comparator covered by the French LPPR, known as the "usual prosthesis".
The main hypothesis being that wearing the SPCM increases the time spent flat-footed in the various walking situations of everyday life, bringing it closer to that of asymptomatic people.
This is a prospective, multicenter, randomized, cross-over study. The participants are transfemoral amputees who have been fitted with a microprocessor-controlled prosthetic knee for more than 3 months.
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:
* Amputee at or above knee level
* Person fitted for more than 3 months with a microprocessor-controlled knee support phase and oscillating phase, in accordance with the conditions for reimbursement set out in the LPPR.
* Person with a level of activity according to the International Classification of of Functioning, Disability and Health greater than or equal to d4602 (moving around outside the house and other buildings)
* Person able to understand simple commands, to read and write, and to give their informed consent
* Person who has given informed consent
* Person affiliated to a social security scheme
Exclusion Criteria:
* Minor
* Person of full age subject to a legal protection measure or unable to express consent
* Pregnant or breast-feeding women
* Persons with bilateral amputations
* Person with a neurological or orthopedic pathology with major repercussions on locomotion
* Persons with a ground/knee height of less than 43.5 cm or more than 55 cm
* Persons weighing more than 125 kg
* Foot size less than 24 cm or greater than 30 cm
* Person with a hip disarticulation
* Person without an emergency walking solution
* Person with a suspension fitting with vacuum pump
* Person planning a trip outside Europe or unable to return in less than 24 hours (in case of device failure) for the duration of the protocol.
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
Comparison of the time (measured as a percentage of the gait cycle) when the foot is flat on the ground during walking in three gait situations: flat, on a slope and going down stairs, with SPCM and the usual prosthesis.
Timeframe: Evaluation after 4 weeks' wear of each of the 2 prostheses