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

NCT ID: NCT02765035

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-05-30

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.

Conditions

Lower Limb Amputation Above Knee (Injury)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

C-Leg 3, then C-Leg 4

Participants are first fitted with a C-Leg 3, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 4, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic.

Group Type: EXPERIMENTAL

C-Leg 4

Intervention Type: DEVICE

Microprocessor Controlled Knee

C-Leg 3

Intervention Type: DEVICE

Microprocessor Controlled Knee

C-Leg 4, then C-Leg 3

Participants are first fitted with a C-Leg 4, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 3, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic.

Group Type: EXPERIMENTAL

C-Leg 4

Intervention Type: DEVICE

Microprocessor Controlled Knee

C-Leg 3

Intervention Type: DEVICE

Microprocessor Controlled Knee

Interventions

C-Leg 4

Microprocessor Controlled Knee

Intervention Type: DEVICE

C-Leg 3

Microprocessor Controlled Knee

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otto Bock Healthcare Products GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Domayer, Prim.Dr.

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Rehabilitation Center

Locations

Orthopedic Rehabilitation Center SKA Zicksee

Sankt Andrä am Zicksee, Burgenland, Austria

University Leuven

Pellenberg, , Belgium

Countries

Austria; Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PD-PS00120010A-001

Identifier Type: -

Identifier Source: org_study_id