MPK vs NMPK Prosthetics for Above-Knee Amputation

(ASCENT K2 Trial)

Not currently recruiting at 238 trial locations

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Otto Bock Healthcare Products GmbH

Disqualifiers: Upper limb involvement, Active malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of knee prosthetics for individuals with an above-knee amputation. Researchers aim to compare advanced microprocessor-controlled knees (MPK), such as the Kenevo or C-Leg 4, with traditional non-microprocessor knees (NMPK) in terms of mobility and daily activities. Participants must have an above-knee amputation, have used a prosthetic for at least 4 months, and be able to walk with some assistance (classified as K2 ambulators). The trial specifically targets those who are 65 years or older and can communicate in English or Spanish. As an unphased trial, it offers a unique opportunity to contribute to research that could improve prosthetic technology and enhance the quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these prosthetic devices are safe for above-knee amputees?

Research has shown that microprocessor-controlled prosthetic knees, such as the Kenevo and C-Leg 4, offer many benefits for individuals with above-knee amputations. These devices help reduce falls, a major concern for users. In past studies, users of these prosthetic knees reported feeling safer and more satisfied with their mobility.

The Kenevo and C-Leg 4 are designed to provide better stability and support, particularly for those who are not very active. Studies have not reported any major safety issues, indicating that these prosthetics are generally safe and well-tolerated.

For those considering joining a trial to test these prosthetics, current evidence suggests they are a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of microprocessor-controlled knees (MPK) in prosthetics for above-knee amputations because of their advanced capabilities compared to non-microprocessor-controlled knees (NMPK). Unlike traditional prosthetics, MPKs like the Kenevo and C-Leg 4 use sensors and microprocessors to adapt to different walking speeds and terrains, providing a more natural and stable gait. This technology can significantly improve balance and reduce the risk of falls, which is a major concern for amputees. Additionally, MPKs require less effort from the user, which can lead to increased comfort and energy efficiency during daily activities. Overall, these features could enhance the quality of life for individuals using prosthetics after an above-knee amputation.

What evidence suggests that this trial's prosthetic treatments could be effective for above-knee amputation?

Research has shown that advanced prosthetic knees, such as the Kenevo or C-Leg 4, included in the MPK arm of this trial, can reduce the risk of falls by up to 80% for individuals with above-knee amputations. These prosthetics feature built-in computers that facilitate smoother movement. Some studies suggest they are particularly beneficial for older adults, enhancing balance and stability. The C-Leg 4, specifically, is designed to make standing easier than its previous version. Overall, these prosthetics hold promise for improving safety and daily activities for those with above-knee amputations. Participants in this trial will be compared to those using a non-microprocessor controlled knee (NMPK), which serves as the active comparator arm. ^{1 3 6 7 8}

Who Is on the Research Team?

Andreas Kannenberg, MD, PhD

Principal Investigator

Otto Bock Healthcare Products GmbH

Shane Wurdeman, PhD

Principal Investigator

Hanger Clinic: Prosthetics & Orthotics

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who have had an above-knee amputation and are currently using a prosthesis they received between 4-24 months ago. They must be K2 ambulators, comfortable with their socket (score of at least 6/10), and speak English or Spanish. People over 275 lbs, with limb issues, multiple socket changes, serious health declines, cancer, or those pregnant cannot join.

Inclusion Criteria

I can walk with some assistance.

You had surgery to replace a body part with an artificial one, and it happened between 4 to 24 months ago.

You currently have a prosthetic device.

Exclusion Criteria

I have had my opposite limb amputated.

I am unable to understand and agree to the study's details on my own.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Initial 12-month period to address Aim 1, focusing on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities

12 months

Phase 2

Monitoring from 12 months to 5 years to address Aim 2, focusing on long-term effects of MPK technology, including reducing morbidity

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Kenevo or C-Leg 4
• Non microprocessor controlled knee (NMPK)

Trial Overview The study compares two types of knee prostheses in people who've lost a leg above the knee: microprocessor-controlled knees (like Kenevo or C-Leg 4) versus non-microprocessor knees. Participants will be randomly assigned to one of these options to see which works better for daily activities.

How Is the Trial Designed?

Group I: MPK Experimental Treatment 1 Intervention

Microprocessor controlled knee

Group II: NMPK Active Control 1 Intervention

Non-microprocessor controlled knee

Who Is Running the Clinical Trial?

Otto Bock Healthcare Products GmbH

Lead Sponsor

Trials

16

Recruited

880+

Hanger Clinic: Prosthetics & Orthotics

Collaborator

Trials

11

Recruited

520+

Published Research Related to This Trial

A study involving 35 individuals with transfemoral amputation showed that microprocessor-controlled knees (MPKs) significantly improved dynamic balance and functional mobility compared to non-MPKs, as evidenced by faster Timed-Up and Go test times and higher Locomotor Capability Index scores.

Participants using MPKs reported higher satisfaction and improved quality of life, particularly in mental health, with no significant difference in fall rates between the two types of prostheses, suggesting that MPKs can be beneficial for amputees with moderate activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobility and satisfaction with a microprocessor-controlled knee in moderately active amputees: A multi-centric randomized crossover trial. Lansade, C., Vicaut, E., Paysant, J., et al.[2022]

Microprocessor-controlled prosthetic knees (MPKs) can significantly reduce uncontrolled falls by up to 80% and improve fall risk indicators for individuals with transfemoral amputation classified as MFCL-2, based on a review of six studies involving 57 subjects.

Users of MPKs may experience improved walking speeds, with a 14% to 25% increase on level ground, a 20% increase on uneven surfaces, and a nearly 30% faster descent on slopes, suggesting enhanced mobility and safety for limited community ambulators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of microprocessor-controlled prosthetic knees to limited community ambulators: systematic review. Kannenberg, A., Zacharias, B., Pröbsting, E.[2022]

Microprocessor-controlled prosthetic knees (MPKs) significantly reduce falls and fear of falling in limited community ambulators, based on a systematic review of 13 studies involving 2366 patients, with 704 classified as limited community ambulators.

MPKs also improve mobility, walking speed, and patient-reported ambulation, making them a valuable therapeutic option for individuals with transfemoral amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of microprocessor controlled exo-prosthetic knees on limited community ambulators: systematic review and meta-analysis. Hahn, A., Bueschges, S., Prager, M., et al.[2023]

Microprocessor prosthetic knees (MPKs) significantly improve functional status and quality of life for patients with lower limb amputation compared to non-microprocessor prosthetic knees (NMPKs), based on a systematic review of 18 studies involving up to 602 participants.

While MPKs show clear advantages over NMPKs, the specific benefits of more advanced models like the Genium® compared to others like the C-leg® and Rheo knee® are not well established, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of microprocessor prosthetic knee on mobility and quality of life in patients with lower limb amputation: a systematic review of the literature. Thibaut, A., Beaudart, C., Maertens DE Noordhout, B., et al.[2023]

A 13-month clinical trial with 10 participants (average age 63) showed that individuals with transfemoral amputations classified as MFCL level K2 experienced significant improvements in gait performance, safety, and self-reported mobility when using a microprocessor-controlled knee (MPK) combined with a 1M10 foot, compared to their previous non-microprocessor knee (NMPK).

The improvements in clinical scores for gait speed, balance, and fall safety were comparable to those seen in individuals with a higher functional level (K3), suggesting that advanced prosthetic technology can enhance the quality of life for K2 level amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a microprocessor knee (C-Leg) with appropriate foot transitioned individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial. Jayaraman, C., Mummidisetty, CK., Albert, MV., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9554759/

The Kenevo microprocessor-controlled prosthetic knee ... Results of the modeling suggest that the Kenevo/MPK is likely to be cost-effective for elderly individuals, primarily because of a reduction in falls.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144349/

Prosthetic rehabilitation for bilateral transfemoral amputees ... We report rehabilitation outcomes in two individuals with bilateral transfemoral amputations that used Kenevo (Ottobock, Germany), a microprocessor-controlled ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06937242

Effects of Microprocessor-controlled Prosthetic Knees on ... The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health ...

4. withpower.com withpower.com/trial/phase-amputation-traumatic-3-2025-6bc1c

Microprocessor-controlled Prosthetic Knees for Above ... Microprocessor-controlled prosthetic knees (MPKs) can significantly reduce uncontrolled falls by up to 80% and improve fall risk indicators for individuals with ...

5. trial.medpath.com trial.medpath.com/clinical-trial/8c5f55c7c8d1540c/randomized-blinded-cross-over-trial-microprocessor-controlled-prosthetic-knee-component

C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees The newly developed C-Leg 4 aims to provide improved standing function while in the same time offering technology of knee´s previous version (C-Leg 3).

6. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2025.2530172

ASsessing Clinical outcomes with microprocEssor kNee ... The advent of the microprocessor knee (MPK) brought multiple clinical benefits for individuals with above-knee amputation (AKA) [1–6].

7. researchgate.net researchgate.net/publication/319246795_Effects_of_a_Novel_Microprocessor-Controlled_Knee_Kenevo_on_the_Safety_Mobility_and_Satisfaction_of_Lower-Activity_Patients_with_Transfemoral_Amputation

Effects of a Novel Microprocessor-Controlled Knee Kenevo ... In a 13-year period, 24 patients with above knee amputation following unsuccessful knee replacement were referred for prosthetic limb fitting.

8. ottobock.com ottobock.com/en-us/product/3C60-60927

Kenevo | A new option for enhanced safety and increased ... This prosthetic knee was designed to provide you with a greater sense of security so you can live the life you deserve. Microprocessor-controlled knees have ...