Clinical trial NCT02765035: C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
Official title: A Randomized, Blinded, Cross-over Trial to Evaluate the Safety, Functional Mobility and Satisfaction of the Microprocessor Controlled Prosthetic Knee Component C-Leg 4 in Transfemoral Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation Above Knee (Injury)
Lead sponsor: Otto Bock Healthcare Products GmbH
Sponsor class: INDUSTRY
First posted: 2016-05-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: During the last two decades many microprocessor controlled knee joints (MPK) appeared on the market.The newly developed C-Leg 4 aims to provide improved standing function while in the same time offering technology of knee´s previous version (C-Leg 3). Since added functional benefit of a knee joint cannot be anticipated just due to the fact that the knee is controlled by the microprocessor, the aim of this post-market study is to evaluate the safety, functional mobility and satisfaction of the microprocessor controlled prosthetic knee components C-Leg 3 and C-Leg 4 in comparison to mechanical knee joints. Additional goal is to improve the methodological quality of research conducted in the field.

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.

Primary outcomes:
measure: Change in 6 Minute Gait Test
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
Secondary outcomes:
measure: Change in 10 Meter Gait Test
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
measure: Change in Stairs Assessment Index (SAI)
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
measure: Change in Hill Assessment Index (HAI)
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
measure: Change in Four Step Square Test (FSST)
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
measure: Change in Activities-specific Balance Confidence (ABC) Scale
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
measure: Change in Prosthetic Limb Users Survey of Mobility (PLUS-M)
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
measure: Change in Amputee Body Image Scale (ABIS)
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
measure: Change in Number of Stumbles and Falls
timeFrame: Baseline and after acclimation period (30-90 days after fitting)
measure: Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)
timeFrame: At 3rd study visit after having been fitted and acclimatized to each of the study devices
Other outcomes:
Locations:
city: Sankt Andrä Am Zicksee
country: Austria
facility: Orthopedic Rehabilitation Center SKA Zicksee
state: Burgenland
city: Pellenberg
country: Belgium
facility: University Leuven
Study officials:
affiliation: Orthopedic Rehabilitation Center
name: Stephan Domayer, Prim.Dr.
role: PRINCIPAL_INVESTIGATOR
References: