CompletedNot Applicable

Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis

United States25 participantsStarted 2011-01

Plain-language summary

The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.

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: * Unilateral transfemoral or knee-disarticulation amputee * 18 to 85 years of age * K3 (variable cadence and community) ambulators; * Current use of and experience with the C-Leg for at least 1 year * Ability to descend stairs and hills without caregiver and assistive devices * Be able to independently provide informed consent * Be willing to comply with study procedures. Exclusion criteria: * History of chronic skin breakdown on the residual limb * Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking) * Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate * Unwillingness/inability to follow instructions

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

75 Meter Self Selected Walking Test

Timeframe: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

Physical Functional Performance (Continuous Scale; 10-items)

Timeframe: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.

Trial details

NCT IDNCT01473992

SponsorJason Highsmith

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-02

Results submitted2014-05-06

View on ClinicalTrials.gov More Other and Unspecified Complications of Amputation Stump trials