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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

ASCENT K2 Trial Summary

This trial is testing whether microprocessor controlled knee prostheses (MPK) are better than non-microprocessor controlled knee prostheses (NPMK) for people with a transfemoral/knee disarticulation level amputation who can walk (K2 ambulators).

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.Check my eligibility
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.See study design
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.

ASCENT K2 Trial 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.

ASCENT K2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
10-meter Walk Test (10mWT)
12-month fall count from bi-weekly fall journal
Average daily step counts
+4 more

ASCENT K2 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

Find a Location

Who is running the clinical trial?

Otto Bock Healthcare Products GmbHLead Sponsor
15 Previous Clinical Trials
730 Total Patients Enrolled
Hanger Clinic: Prosthetics & OrthoticsOTHER
9 Previous Clinical Trials
288 Total Patients Enrolled
Andreas Kannenberg, MD, PhDPrincipal InvestigatorOtto Bock Healthcare Products GmbH

Media Library

Kenevo or C-Leg 4 (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04784429 — N/A
Above Knee Amputation Research Study Groups: MPK, NMPK
Above Knee Amputation Clinical Trial 2023: Kenevo or C-Leg 4 Highlights & Side Effects. Trial Name: NCT04784429 — N/A
Kenevo or C-Leg 4 (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784429 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining spots available for volunteers in this clinical trial?

"As per clinicaltrials.gov, this medical trial is no longer enlisting patients; the first posting was on June 11th 2021 and it has been subsequently edited as recently as November 16th 2022. Nonetheless, there are still 7 other trials that require participants at present."

Answered by AI

How many locations are carrying out this clinical experiment in the state?

"Patients can enrol in this trial at the Hanger Clinic - Meridian, Mississippi (1903 23rd Ave), Hanger Clinic - Pennsylvania (2108 Harrisburg Pike Suite 308) and other numerous locations. Notably, there is a location in Knoxville, Michigan as well."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
How old are they?
18 - 65
What site did they apply to?
Hanger Clinic - Michigan - 2314 Gull Road
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
2021. "Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04784429.
~28 spots leftby Apr 2025
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