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