What side effects are associated with this type of intervention?

The most common treatments for above-knee amputation include the use of prosthetic limbs, particularly microprocessor-controlled knee prostheses (MPK). Known side effects of using MPKs include skin irritation and sores at the site of prosthetic attachment, phantom limb pain, and occasional mechanical issues with the prosthetic device. Additionally, there may be a learning curve associated with adapting to the new prosthesis, which can temporarily affect balance and gait. However, MPKs have been shown to reduce fall incidents, improve balance confidence, and enhance walking performance on various terrains compared to non-microprocessor-controlled prosthetic knees.

What prior FDA approvals exist?

The FDA has approved several microprocessor-controlled knee prostheses (MPK) for the treatment of above-knee amputation. These devices, such as the Ottobock C-Leg and the Ossur Rheo Knee, utilize real-time adaptive control to improve mobility and stability for amputees. These advanced prosthetic knees adjust to the user's walking speed and terrain, providing a more natural gait and reducing the risk of falls. While the focus is on the prosthetic devices themselves, rather than specific drugs, these innovations represent significant advancements in the rehabilitation and quality of life for individuals with above-knee amputations.

What other types of research exist?

Promising novel alternatives to Microprocessor Controlled Knee Prostheses for Above Knee Amputation patients include: 1) Osseointegrated percutaneous implants, which offer direct skeletal attachment and improved proprioception. 2) Advanced robotic exoskeletons that provide enhanced mobility and support. 3) Neuroprosthetics that integrate with the nervous system for more intuitive control. 4) Wearable robots with biomechanical loading to reduce the effort required for movement. These technologies are in various stages of development and clinical testing, showing potential for improved outcomes in 2024.

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Prosthetic Device

MPK vs NMPK Prosthetics for Above-Knee Amputation (ASCENT K2 Trial)

N/A

Waitlist Available

Led By Andreas Kannenberg, MD, PhD

Research Sponsored by Otto Bock Healthcare Products GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 65 years at Baseline Assessment (one month after enrollment)

Unilateral transfemoral or knee disarticulation amputation

Must not have

Amputation of the contralateral limb

Unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not typical side effects as seen with medications, participants may experience discomfort adjusting to new prosthetic technology such as skin irritation at the site of contact with the prosthesis or difficulty adapting to its function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I have had an amputation above or through my knee on one leg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had my opposite limb amputated.

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

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I currently have cancer.

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I am unable or unwilling to follow the study's required procedures.

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I have had 2 or more adjustments or replacements of my prosthetic socket in the last 6 months.

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I am not pregnant, institutionalized, or a child.

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I have had issues with my amputated limb not healing properly.

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I weigh 275 lbs or more.

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My upper limb is affected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

10-meter Walk Test (10mWT)

12-month fall count from bi-weekly fall journal

Average daily step counts

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MPKExperimental Treatment1 Intervention

Microprocessor controlled knee

Group II: NMPKActive Control1 Intervention

Non-microprocessor controlled knee

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Microprocessor Controlled Knee Prostheses (MPK) utilize real-time adaptive control of the knee joint through sensors and microprocessors that continuously monitor the user's gait and adjust the knee's resistance and movement. This technology provides a more natural and efficient walking pattern, reduces the risk of falls, and improves overall mobility and quality of life for Above Knee Amputation (AKA) patients. These mechanisms are crucial as they directly impact rehabilitation outcomes, functional independence, and daily living activities for AKA patients.

Osseointegrated Prosthetic Implants for People With Lower-Limb Amputation: A Health Technology Assessment.