Microprocessor-Controlled Prosthetic Knee for Amputation

(MPK-K2 Trial)

Not yet recruiting at 1 trial location

Overseen By Steven A Gard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Bilateral amputations, Knee disarticulation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new type of prosthetic knee, the microprocessor-controlled knee (MPK), provides better physical and psychological benefits than the usual non-microprocessor-controlled knee (NMPK). The MPK automatically adjusts to assist with walking, potentially making movement easier and more comfortable. Veterans with a single, above-the-knee amputation who have used a prosthetic for at least a year and have a good fit and sensation in their current prosthetic leg may qualify for this study. Participants will first be tested using their current NMPK and then with the MPK after a two-month adjustment period. As an unphased trial, this study allows veterans to contribute to innovative research that could enhance prosthetic technology for future users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this microprocessor-controlled prosthetic knee is safe for use in Veterans with transfemoral amputations?

Research has shown that microprocessor-controlled prosthetic knees (MPKs), such as the College Park ICON, are generally safe for users. These knees automatically adjust to improve walking control, reducing falls and enhancing stability. Studies of individuals with above-the-knee limb loss found that MPKs enhance walking ability without major safety concerns.

Users of MPKs reported feeling more confident and stable while walking, even on uneven surfaces like ramps and stairs. This boost in confidence is important because it can lead to a more active and independent lifestyle. Studies have not commonly reported major negative side effects, suggesting that MPKs are well-tolerated by users.

While MPKs may have some minor issues, evidence suggests they are a safe option for those seeking to improve mobility and quality of life. Discussing specific safety concerns with a healthcare provider is a good next step. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the College Park ICON microprocessor-controlled prosthetic knee (MPK) because it offers a significant upgrade over conventional non-microprocessor prosthetic knees (NMPK). Unlike standard prosthetics, which rely on mechanical systems, the ICON MPK uses advanced sensors and microprocessors to adapt in real-time to the user's movements and the terrain. This can result in smoother walking, better stability, and decreased risk of falls, which are major concerns with traditional prosthetic knees. By providing a more natural walking experience, the ICON MPK has the potential to significantly improve the quality of life for individuals with lower limb amputations.

What evidence suggests that this microprocessor-controlled knee is effective for improving mobility in veterans with transfemoral amputations?

Research shows that the College Park ICON MPK, which participants in this trial will use, helps individuals with above-knee amputations walk more naturally. It automatically adjusts to enhance walking and balance. Studies have found that these prosthetic knees improve users' ability to perform daily activities and boost confidence, even on uneven ground, ramps, and stairs. They also reduce strain on the other leg. Overall, these prosthetic knees can enhance both physical ability and mental well-being for those with above-knee amputations. ^{1 5 6 7 8}

Who Is on the Research Team?

Steven A Gard, PhD

Principal Investigator

Jesse Brown VA Medical Center, Chicago, IL

Are You a Good Fit for This Trial?

This trial is for Veterans with unilateral, transfemoral amputations who are currently using a nonmicroprocessor-controlled knee (NMPK). They should be able to walk at a K2 level, which means they have the ability to traverse low-level environmental barriers such as curbs and stairs.

Inclusion Criteria

Good sensation on their residual limb

I have had one leg amputated above the knee.

I am between 45 and 85 years old.

Exclusion Criteria

I have had both of my legs amputated.

I have had a knee disarticulation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants are evaluated using their conventional NMPK to establish baseline measures

1 week

1 visit (in-person)

Accommodation Period

Participants are fitted with the College Park Icon MPK and allowed a 2-month accommodation period

8 weeks

1 visit (in-person) at the start

Post-Accommodation Evaluation

Participants are evaluated after the accommodation period with the MPK to assess changes in mobility and psychological well-being

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• College Park ICON

Trial Overview The study is testing if a microprocessor-controlled prosthetic knee joint (College Park ICON) offers physical and psychological benefits over conventional NMPKs. Participants will use their current NMPK and then switch to the ICON MPK for two months before being evaluated.

How Is the Trial Designed?

Group I: MPK Experimental Treatment 1 Intervention

Subjects will be fitted with the College Park ICON MPK and permitted to accommodate for 2 months prior to data collection.

Group II: NMPK Active Control 1 Intervention

Subjects will initially be evaluated walking on their conventional NMPK as a baseline prior to being fitted with the MPK.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07103798

Effect of a Microprocessor-controlled Prosthetic Knee Joint ... Aim 2: To determine the effects of the College Park Icon on the psychological well-being of unilateral, transfemoral prosthesis users. The ...

2. withpower.com withpower.com/trial/phase-transfemoral-amputation-2026-03cfa

Microprocessor-Controlled Prosthetic Knee for Amputation ... ... College Park ICON will have tolerable side effects & efficacy for patients with Below Knee Amputation, Amputation and Amputation. Learn more about the study.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7646606/

Effects of microprocessor-controlled prosthetic knees on ... Our data suggest that the MPKs improved the patients' abilities to perform locomotor abilities and activities of daily living, and they showed positive effects ...

4. metroprosthetics.com metroprosthetics.com/college-park-icon-knee-review/

College Park Icon Knee: Full Review, Features, and Specs Its goal: to help amputees walk more naturally, reduce strain on the sound limb, and improve confidence across uneven ground, ramps, and stairs.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06937242

Effects of Microprocessor-controlled Prosthetic Knees on ... This study aims to assess the effects of microprocessor-controlled prosthetic knees on fall-related health outcomes in prosthesis users classified as limited ...

6. locomotor.ahs.uic.edu locomotor.ahs.uic.edu/wp-content/uploads/sites/481/2020/12/PDF4.pdf

JRRD Volume 50, Number 3, 2013 Abstract—Microprocessor-controlled prosthetic knees (MPKs) have been developed as an alternative to non-microprocessor- controlled knees (NMPKs) to address ...

7. researchgate.net researchgate.net/publication/307691863_Outcomes_associated_with_the_use_of_microprocessor-controlled_prosthetic_knees_among_individuals_with_unilateral_transfemoral_limb_loss_A_systematic_review

(PDF) Outcomes associated with the use of microprocessor ... Outcomes associated with the use of microprocessor-controlled prosthetic knees among individuals with unilateral transfemoral limb loss: A ...

8. hca.wa.gov hca.wa.gov/assets/program/mc_lower_prosthetic_final_report[1].pdf

Microprocessor-controlled Lower Limb Prostheses 68 The prosthetic knee is commonly selected to provide both the stability (safety) and agility (responsiveness) required by the user ...