Microprocessor-controlled Prosthetic Knees for Above Knee Amputation

Overseen By Bretta L. Fylstra, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hanger Institute for Clinical Research and Education, LLC

Disqualifiers: Weight over 275 lbs, Limb breakdown, Reduced activity, others

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

Compensation: Varies

Number of Visits: 9

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether microprocessor-controlled prosthetic knees (MPKs), equipped with built-in computers, can reduce fall-related health issues and improve mobility, walking speed, and quality of life for individuals with above-knee amputations. It compares MPKs, such as the Ottobock C-Leg 4 Microprocessor Knee and the Ottobock Kenevo, to traditional prosthetic knees without microprocessors. Participants who have recently switched to a non-microprocessor knee and can walk in their community with some limitations are well-suited for this study. Participants will either continue using their current prosthesis or receive a new MPK to test these outcomes. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance prosthetic technology and improve lives.

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 microprocessor-controlled prosthetic knees are safe for above-knee amputees?

Research has shown that advanced prosthetic knees, such as the Ottobock C-Leg 4, are generally safe for individuals with leg amputations. Studies have found that these knees help reduce falls and improve balance compared to standard prosthetic knees. Specifically, the C-Leg 4 significantly lowers the number of falls, demonstrating a high level of safety.

For the Ottobock Kenevo, research suggests it also enhances safety and mobility. One study found that 89% of users preferred the Kenevo over their previous knee, highlighting its effectiveness and user satisfaction.

Both the C-Leg 4 and Kenevo are well-accepted options for those with an above-knee amputation, offering improved mobility and a reduced risk of falling. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about microprocessor-controlled prosthetic knees, like the Ottobock C-Leg 4 and Ottobock Kenevo, because they offer dynamic adjustments that traditional prosthetics can't. Unlike standard prosthetics, these high-tech knees use sensors to adapt to walking speed and terrain in real-time, enhancing stability and reducing the risk of falls. They also provide a more natural walking experience by automatically adjusting to different activities, such as walking on slopes or stairs. This innovation could significantly improve mobility and quality of life for those with above-knee amputations.

What evidence suggests that microprocessor-controlled prosthetic knees are effective for improving health outcomes related to falls?

Research has shown that advanced prosthetic knees with microprocessors, such as the Ottobock C-Leg 4 and Kenevo, enhance safety and ease of walking for individuals with above-knee amputations. In this trial, participants in the experimental arm will receive either the Ottobock C-Leg 4 or Kenevo, based on the manufacturer's recommended patient-selection criteria. Studies have found that these high-tech knees lower the risk of falls, providing a significant benefit for users. They offer a more stable walking experience by adjusting to different speeds and surfaces. The Kenevo model is particularly beneficial for older adults, as it reduces health issues related to falls. Overall, these prosthetic knees improve mobility and quality of life by offering a smoother and safer walking experience. ^{1 2 3 5 6}

Who Is on the Research Team?

Shane R. Wurdeman, PhD

Principal Investigator

Hanger Institute for Clinical Research and Education

Are You a Good Fit for This Trial?

This trial is for adults who have had an above-knee amputation and currently use a non-microprocessor-controlled prosthetic knee. Ideal candidates should be limited community ambulators looking to improve their mobility.

Inclusion Criteria

I lost a limb more than 12 months ago.

Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months

I use a prosthetic knee that does not have a microprocessor.

Exclusion Criteria

I weigh 275 lbs or more.

Individuals with a history of acute or chronic residual limb breakdown

I wear my prosthesis for less than 3 days or under 24 hours a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are assessed at baseline after enrollment and randomization

1 day

1 visit (in-person)

Treatment

Participants receive either a non-microprocessor knee (nMPK) or a microprocessor-controlled knee (MPK) and undergo training sessions

12 months

6 visits (in-person) at 1, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for fall-related health outcomes, mobility, and quality of life

12 months

Regular contact every 2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ottobock C-Leg 4 Microprocessor Knee
• Ottobock Kenevo

Trial Overview The study tests if microprocessor-controlled prosthetic knees (MPKs) with built-in computers can reduce fall-related health issues, increase mobility, speed up walking, and enhance quality of life compared to standard prostheses.

How Is the Trial Designed?

Group I: MPK (Ottobock C-Leg 4 or Ottobock Kenevo) Experimental Treatment 2 Interventions

The MPK provided to each participant in the intervention arm will be determined by the manufacturer's recommended patient-selection criteria.

Group II: nMPK Active Control 1 Intervention

Participants in the control arm of the trial will remain in their prescribed non-microprocessor knee (nMPK) prosthesis

Who Is Running the Clinical Trial?

Hanger Institute for Clinical Research and Education, LLC

Lead Sponsor

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

U.S. Army Medical Research Acquisition Activity

Collaborator

Trials

26

Recruited

10,500+

Published Research Related to This Trial

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]

Commercial microprocessor-controlled prosthetic knees (MPKs) are mostly passive and rely on heuristic intent classifiers, while research MPKs are powered and often use machine learning for better intention detection, indicating a significant technological gap.

The main challenges for the commercial viability of active MPKs include demonstrating their benefits over passive models, evaluating their performance in real-world settings, and ensuring that control parameters remain practical for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Control Strategies in Commercial and Research Knee Prostheses. Fluit, R., Prinsen, EC., Wang, S., et al.[2021]

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]

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]

Citations

1. ottobock.com ottobock.com/en-us/c-leg4

C-Leg 4 Microprocessor Knee | Choose Proven Performance With its innovative design and exciting new features, C-Leg 4 provides a highly personalized user experience that helps you move more easily through your day.

2. 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.

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 ... Research shows that microprocessor-controlled prosthetic knees, like the Ottobock C-Leg 4 and Kenevo, improve safety, balance, and walking speed for people with ...

5. ottobock.com ottobock.com/en-us/product/3C88-3-3C98-3-22923

C-Leg 4 | Choose the latest in proven performance C-Leg 4 ; Product type, Microprocessor ; Mobility grade, 2, 3, 4 ; Max. body weight, 300 lbs ; Amputation level, Hip disarticulation, Transfemoral amputation, Knee ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8146219/

Using a microprocessor knee (C-Leg) with appropriate foot ... We conducted a 13 month longitudinal clinical trial to determine the benefits of using a C-Leg and 1M10 foot in individuals at K2 level with transfemoral ...