Powered Prosthetic Knee for Below Knee Amputation

Recruiting in Loma Linda (>99 mi)

Overseen By Michael Davidson, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Multiple amputations, Assistive device, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.

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 Powered Microprocessor-Controlled Knee (PMPK) for below knee amputation?

Research shows that microprocessor-controlled prosthetic knees (MPKs) improve mobility and quality of life for people with lower limb amputations. They offer benefits in safety and performance, especially for those who walk in their communities. ^{1 2 3 4 5}

Is the powered prosthetic knee generally safe for humans?

Research shows that microprocessor-controlled prosthetic knees (MPKs) have been evaluated for safety, with studies indicating benefits in safety and performance for users, including those with lower activity levels. ^{1 2 3 4 5}

How is the Powered Prosthetic Knee treatment different from other treatments for below knee amputation?

The Powered Prosthetic Knee (PMPK) is unique because it uses advanced technology to improve mobility and quality of life for people with lower limb amputations. Unlike traditional prosthetics, it includes a microprocessor that helps control the knee's movement, making it more responsive and adaptable to different walking conditions. ^{1 2 3 5 6}

Research Team

Michael Davidson, Ph.D.

Principal Investigator

Loma Linda University Health

Eligibility Criteria

This trial is for men and women aged 18-75 who have lost one leg above the knee, weigh between 49-117 kg, walk or play sports with a prosthesis daily, and have been doing so for at least six months without recent socket issues or limb pain that affects function.

Inclusion Criteria

No socket issues or changes in the last six weeks

No residual limb pain affecting functional ability.

Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Initial Visit

Informed consent, HIPAA authorization, ambulation potential verification, body measurements, balance confidence scale, posture alignment assessment

1 day

1 visit (in-person)

Second Visit

Fit with heart rate monitor and metabolic analyzer, treadmill tests, posture alignment assessment, use PMPK for one week

1 week

1 visit (in-person)

Third Visit

Fit with heart rate monitor and metabolic analyzer, treadmill tests, balance confidence scale, return PMPK, verify alignment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• PMPK

Trial Overview The study aims to determine if a powered microprocessor-controlled knee (PMPK) can improve how efficiently people use energy while walking on flat ground and slopes compared to their usual physician-prescribed prosthetic knees.

Participant Groups

Group I: Powered Microprocessor-controlled Knee (PMPK) Experimental Treatment 1 Intervention

the "Power Knee" is a commercially available PMPK.

PMPK is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as PMPK for:

• Lower limb loss
• Mobility assistance

Approved in United States as PMPK for:

• Lower limb loss
• Mobility assistance

Approved in Canada as PMPK for:

• Lower limb loss
• Mobility assistance

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Össur Ehf

Industry Sponsor

Trials

23

Recruited

3,900+

Össur Iceland ehf

Industry Sponsor

Trials

23

Recruited

3,900+

Findings from Research

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]

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]

The pilot study involving five elderly transfemoral amputees showed that using a microprocessor-controlled knee prosthesis (MPK) improved perceptions of safety and resulted in more natural gait patterns compared to standard non-microprocessor-controlled knee prostheses (NMPK) after just 4 to 6 weeks of familiarization.

However, the study suggests that without structured training and a longer acclimation period, the functional benefits of the MPK may not be fully realized, indicating that additional support may be necessary for optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and function of a prototype microprocessor-controlled knee prosthesis for low active transfemoral amputees switching from a mechanic knee prosthesis: a pilot study. Hasenoehrl, T., Schmalz, T., Windhager, R., et al.[2018]

In a study of 45 low-activity transfemoral amputees transitioning from mechanical knees to microprocessor knees (MPKs), significant improvements were observed in balance, walking distance (measured by the two-minute walk test), and confidence, despite no significant changes in health-related quality of life or gait profile score.

The findings suggest that while MPKs may not drastically change overall quality of life or gait metrics, they can enhance functional mobility and reduce falls, indicating potential benefits for low-activity users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of patient-reported and functional outcomes following transition from mechanical to microprocessor knee in the low-activity user with a unilateral transfemoral amputation. Davie-Smith, F., Carse, B.[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]

References

1. Italy 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. [2023]

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Safety and function of a prototype microprocessor-controlled knee prosthesis for low active transfemoral amputees switching from a mechanic knee prosthesis: a pilot study. [2018]

5. France pubmed.ncbi.nlm.nih.gov

Comparison of patient-reported and functional outcomes following transition from mechanical to microprocessor knee in the low-activity user with a unilateral transfemoral amputation. [2023]

6. 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]