CompletedNot Applicable

New Microprocessor-Controlled Prosthetic Knee Evaluation

France18 participantsStarted 2023-06-07

Plain-language summary

The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.

Who can participate

Age range

18 Years – 85 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: * Able to understand and give informed consent * Man or woman, more than 18 y.o * Lower limb amputee KD or AKA, unilateral or bilateral * K3/K4 activity level * Already fitted with FR-reimbursed MPK * Being comfortable in their socket (SCS\>=5) Exclusion Criteria: * Protected person * Pregnant or breast feeding lady * Person having pathologies affecting their sensitivity * Using walking aids * Weighting more than 136kg * Insufficient hip joint or pelvic voluntary muscle control * Insufficient cognitive ability to charge the knee and care for the device

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

Personal goal achievement

Timeframe: test sessions 1 and 2 (20 minutes)

Trial details

NCT IDNCT06017024

SponsorProteor Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-11

View on ClinicalTrials.gov More Lower Limb Amputation Above Knee (Injury) trials

Who can participate

Age range

18 Years – 85 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.