MPK vs NMPK Prosthetics for Above-Knee Amputation

(ASCENT K2 Trial)

Recruiting at 237 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

107 Participants Needed

Trial Summary

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 Kenevo or C-Leg 4 for above-knee amputation?

Research shows that using a microprocessor knee like the C-Leg can improve walking ability and reduce falls and stumbles in people with above-knee amputations, compared to non-microprocessor knees. This suggests that advanced prosthetics like the C-Leg can enhance safety and mobility for amputees. ^{1 2 3 4 5}

Is the use of microprocessor-controlled prosthetic knees (like C-Leg) safe for individuals with above-knee amputations?

Research shows that microprocessor-controlled prosthetic knees (MPKs) like the C-Leg are generally safe and can significantly reduce falls and stumbles compared to non-microprocessor knees. They also improve walking speed and stability, making them a safer option for individuals with above-knee amputations. ^{1 2 6 7 8}

How does the treatment with Kenevo or C-Leg 4 prosthetics differ from other treatments for above-knee amputation?

The Kenevo and C-Leg 4 prosthetics are unique because they use microprocessor-controlled knees (MPKs), which improve mobility and quality of life by providing more dynamic movements and reducing stumbles and falls compared to non-microprocessor-controlled knees (NMPKs). This advanced technology is particularly beneficial for amputees with moderate activity levels, offering enhanced safety and performance. ^{1 9 10 11 12}

What is the purpose of this trial?

This trial tests advanced artificial knees with built-in computers in above-knee or knee-level amputees who have limited walking ability. The goal is to see if these knees can reduce fear of falling, improve quality of life, and increase participation in activities. These advanced knees are well-established devices that significantly increase patient safety, walking ability, and performance in daily activities.

Research Team

Andreas Kannenberg, MD, PhD

Principal Investigator

Otto Bock Healthcare Products GmbH

Shane Wurdeman, PhD

Principal Investigator

Hanger Clinic: Prosthetics & Orthotics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

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

Comparison of nonmicroprocessor knee mechanism versus C-Leg on Prosthesis Evaluation Questionnaire, stumbles, falls, walking tests, stair descent, and knee preference. [2022]

2. England 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. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Primary survival and prosthetic fitting of lower limb amputees. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Major lower extremity amputation in patients with peripheral arterial insufficiency with special reference to the transgenicular amputation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effect of depression on prosthesis prescription in men and women who have undergone a lower limb amputation. [2023]

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

Physical function, gait, and dynamic balance of transfemoral amputees using two mechanical passive prosthetic knee devices. [2010]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Longitudinal gait analysis of a person with a transfemoral amputation using three different prosthetic knee/foot pairs. [2022]

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Economic benefits of microprocessor controlled prosthetic knees: a modeling study. [2019]

12. 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]