Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic (NCT04787627) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic
United States17 participantsStarted 2019-11-18
Plain-language summary
Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK).
The primary objective was to evaluate the efficacy of the investigational device in reducing exertion during walking compared to passive MPKs. Additionally to evaluate the efficacy of the investigational device in the short and long term compared to passive MPKs and previous versions of the Power Knee, during daily living activities i.e. walking on level ground, in stairs and inclines, rising from and sitting down to a chair as well as performance of gait functions and ease of set up for average to highly active transfemoral/knee disarticulation amputees and Certified Prosthetists/Orthotists (CPOs).
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:
* 50Kg\< body weight \< 116Kg
* K3-K4 amputees with unilateral transfemoral amputation or Knee disarticulation
* Allows for 37mm knee center height to dome of pyramid alignment
* Currently using a MPK or Power Knee
* Older than 18 years old
* No socket issues/changes in the last 6 weeks and no socket changes expected during the duration of the study period.
* Comfortable and stable socket fit
* Willing and able to participate in the study and follow the protocol
Exclusion Criteria:
* 50Kg\> body weight \> 116Kg
* Bilateral amputees
* Users with socket problems
* Users with co-morbidities in the contra-lateral limb, which affect their functional mobility
* Younger than 18 years old
* Users with stump pain
* Users with cognitive impairment
* Users not involved in other clinical tests and/or receiving treatment that the testing might affect.
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
Mean Difference in Borg Category Rating Scale Before and After 6MWT at 2 Weeks
Timeframe: At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16)
2
Average Distance Walked in 6 Minute Walk Test
Timeframe: At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16)