C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees (NCT02765035) | Clinical Trial Compass
CompletedNot Applicable
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
Austria, Belgium18 participantsStarted 2016-04
Plain-language summary
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.
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:
* Person is \>18 years old.
* Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.
* Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL).
* Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months.
* Person was never fitted with microprocessor controlled prosthetic knee joint.
* Person is willing and able to independently provide informed consent.
* Person is willing to comply with study procedures.
* Person wears prosthesis daily and ≥ 8 hours/day.
* Person is walking on average 1km/day.
* Person is walking not slower than 3km/h (\~0.8m/s) (based on 10m walk test conducted during recruiting).
* Person is walking on level ground in a step over step manner.
Exclusion Criteria:
* Person is under 18 years of age.
* Person who weighs more than 136kg.
* Person who weighs less than 50kg.
* Person who is pregnant.
* Person has a history of chronic skin breakdown on the residual limb.
* Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking).
* Person falls ≥ once a week due to the reasons that could not be corrected by the new prosthesis (for ex. problems with vestibular system).
* Person is using under arm axillary crutches or walker.
* Person in an emergency, life threatening situation.
* Person is u…
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
Change in 6 Minute Gait Test
Timeframe: Baseline and after acclimation period (30-90 days after fitting)