Kenevo or C-Leg 4 for Amputation
Phase-Based Progress Estimates
Effectiveness
Safety
Amputation+2 More
Kenevo or C-Leg 4 - DeviceEligibility
65+
All Sexes
What conditions do you have?
Select
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
Effectiveness Progress
Other trials for Amputation
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
Safety Progress
Other trials for Amputation
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: DeviceNMPK
Device
ActiveComparator Group · 1 Intervention: Non microprocessor controlled knee (NMPK) · Intervention Types: DeviceTrial 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 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?
| Michigan | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Hanger Clinic - Michigan - 2314 Gull Road | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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