N/A N=13 Randomized Double-blind Treatment

C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees

Lower Limb Amputation Above Knee (Injury)

Bottom Line

View on ClinicalTrials.gov: NCT02765035 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Change in 6 Minute Gait Test — 380.4; 380.4; 35.9; 26.7 meters — p=0.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: C-Leg 4 (Device); C-Leg 3 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Otto Bock Healthcare Products GmbH
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in 6 Minute Gait Test	380.4; 380.4; 35.9; 26.7	0.01 sig
SECONDARY Change in 10 Meter Gait Test	1.11; 1.11; 0.00; -0.25; 1.36; 1.36	—
SECONDARY Change in Stairs Assessment Index (SAI)	5; 5; -0.6; 0.0; 4; 4	—
SECONDARY Change in Hill Assessment Index (HAI)	8.4; 8.4; 1.9; 1.1; 7.9; 7.9	—
SECONDARY Change in Four Step Square Test (FSST)	13.5; 13.5; -2.6; -2.4	—
SECONDARY Change in Activities-specific Balance Confidence (ABC) Scale	72.4; 72.4; 1.4; 2.7	—
SECONDARY Change in Prosthetic Limb Users Survey of Mobility (PLUS-M)	50.0; 50; 0.6; 0.8	—
SECONDARY Change in Amputee Body Image Scale (ABIS)	55.1; 55.1; 1.9; -0.4	—
SECONDARY Change in Number of Stumbles and Falls	3.3; 3.3; -0.3; -0.3; 1.0; 1.0	—
SECONDARY Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)	7; 3; 1	—

Summary

The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.

Eligibility Criteria

Inclusion Criteria

Person is >18 years old.
Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.
Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL).
Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months.
Person was never fitted with microprocessor controlled prosthetic knee joint.
Person is willing and able to independently provide informed consent.
Person is willing to comply with study procedures.
Person wears prosthesis daily and ≥ 8 hours/day.
Person is walking on average 1km/day.
Person is walking not slower than 3km/h (~0.8m/s) (based on 10m walk test conducted during recruiting).
Person is walking on level ground in a step over step manner.

Exclusion Criteria

Person is under 18 years of age.
Person who weighs more than 136kg.
Person who weighs less than 50kg.
Person who is pregnant.
Person has a history of chronic skin breakdown on the residual limb.
Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking).
Person falls ≥ once a week due to the reasons that could not be corrected by the new prosthesis (for ex. problems with vestibular system).
Person is using under arm axillary crutches or walker.
Person in an emergency, life threatening situation.
Person is unwilling/unable to follow instructions.
Person who is not available to follow the entire study protocol.
Person who is participating in another study or intends to participate in another study during this study duration.
Person who cannot personally provide their consent.
Person who is not wearing prosthesis 8hours/day on average.
Person who has a score on 10m walk test less than 3km/h (~0.8m/s) (based on 10m walk test conducted during recruiting).
Person who walks on average less than 1km per day.
Person who is not able to walk on level ground in a step over step manner.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02765035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.