Kenevo or C-Leg 4 for Amputation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Amputation+2 More
Kenevo or C-Leg 4 - Device
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions
  • Amputation
  • Congenital Amputation of Lower Limb

Treatment Effectiveness

Study Objectives

0 Primary · 7 Secondary · Reporting Duration: 3 years

12 months
12-month fall count from bi-weekly fall journal
Average daily step counts
3 years
10-meter Walk Test (10mWT)
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)
Timed Up and Go (TUG)

Trial Safety

Trial Design

2 Treatment Groups

NMPK
1 of 2
MPK
1 of 2
Active Control
Experimental Treatment

107 Total Participants · 2 Treatment Groups

Primary Treatment: Kenevo or C-Leg 4 · No Placebo Group · N/A

MPK
Device
Experimental Group · 1 Intervention: Kenevo or C-Leg 4 · Intervention Types: Device
NMPK
Device
ActiveComparator Group · 1 Intervention: Non microprocessor controlled knee (NMPK) · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Hanger Clinic: Prosthetics & OrthoticsOTHER
7 Previous Clinical Trials
246 Total Patients Enrolled
Otto Bock Healthcare Products GmbHLead Sponsor
13 Previous Clinical Trials
485 Total Patients Enrolled
Andreas Kannenberg, MD, PhDPrincipal InvestigatorOtto Bock Healthcare Products GmbH
Shane Wurdeman, PhDPrincipal InvestigatorHanger Clinic: Prosthetics & Orthotics

Eligibility Criteria

Age 65+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
An individual who received a prosthesis between 4 and 24 months prior to the study and currently uses a prosthesis was included in the study.
The patient is in stable condition with K2 ambulator status
This person is bilingual and can speak English or Spanish.
The study participants must be at least 65 years old at the time of the baseline assessment.
required You need a Minimum Socket Comfort Score (SCS) of 6/10 to be comfortable.
You have a unilateral transfemoral or knee disarticulation amputation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Michigan100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Hanger Clinic - Michigan - 2314 Gull Road100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%