Active — Not RecruitingNot Applicable

Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

United States107 participantsStarted 2021-06-11

Plain-language summary

Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Who can participate

Age range

65 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 amputation * Received prosthesis between 4 - 24 months prior * Currently uses prosthesis * K2 ambulator status * Able to speak English or Spanish language * Age ≥ 65 years at Baseline Assessment (one month after enrollment) * Minimum Socket Comfort Score (SCS) of 6/10 Exclusion Criteria: * Upper limb involvement * Individuals ≥ 275 lbs * Unable to provide informed consent * History of acute or chronic residual limb breakdown * History of 2 or more socket adjustments or replacements in the past 6 months * Amputation of the contralateral limb * Active malignancy * Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical \& Scientific Affairs personnel * Patient unable or unwilling to follow study procedures * Pregnant women, institutionalized persons, and children

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

Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

Timeframe: 12 months

Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

Timeframe: 5 years

Trial details

NCT IDNCT04784429

SponsorOtto Bock Healthcare Products GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-29

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

Who can participate

Age range

65 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.