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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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 outcomes related to falls in adults who use above-knee prostheses. The main questions are: * Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)? * Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs? Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.

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 data supports the effectiveness of the treatment Ottobock C-Leg 4 Microprocessor Knee and Ottobock Kenevo for above knee amputation?

Research shows that microprocessor-controlled prosthetic knees, like the Ottobock C-Leg 4 and Kenevo, improve safety, balance, and walking speed for people with above-knee amputations. These knees help reduce falls and increase confidence in walking, making them effective for both active and moderately active users. ^{1 2 3 4 5}

Is the microprocessor-controlled prosthetic knee safe for humans?

Research shows that microprocessor-controlled prosthetic knees are generally safe and can reduce falls and improve balance for people with leg amputations, including those with transfemoral amputations and peripheral artery disease. ^{1 2 3 6 7}

How is the Ottobock C-Leg 4 and Kenevo treatment different from other prosthetic knee options?

The Ottobock C-Leg 4 and Kenevo are unique because they use microprocessor technology to control the knee's movement, which helps improve balance, reduce falls, and enhance walking speed for people with above-knee amputations. This technology offers better safety and function compared to traditional prosthetic knees that do not have microprocessor control. ^{2 3 4 5 8}

Research Team

Shane R. Wurdeman, PhD

Principal Investigator

Hanger Institute for Clinical Research and Education

Eligibility Criteria

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 can walk with some assistance but have limited ability to go out.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of microprocessor controlled exo-prosthetic knees on limited community ambulators: systematic review and meta-analysis. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Enhancement of a prosthetic knee with a microprocessor-controlled gait phase switch reduces falls and improves balance confidence and gait speed in community ambulators with unilateral transfemoral amputation. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Mobility and satisfaction with a microprocessor-controlled knee in moderately active amputees: A multi-centric randomized crossover trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The comparison of transfemoral amputees using mechanical and microprocessor- controlled prosthetic knee under different walking speeds: A randomized cross-over trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Comparative biomechanical analysis of current microprocessor-controlled prosthetic knee joints. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Benefits for Adults with Transfemoral Amputations and Peripheral Artery Disease Using Microprocessor Compared with Nonmicroprocessor Prosthetic Knees. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Benefits of microprocessor-controlled prosthetic knees to limited community ambulators: systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Control Strategies in Commercial and Research Knee Prostheses. [2021]