NCT02765035

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Otto Bock Healthcare Products GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	C-Leg 4	Microprocessor Controlled Knee
DEVICE	C-Leg 3	Microprocessor Controlled Knee

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2016-05-06
• Last updated: 2021-10-14
• Results posted: 2021-10-14

Locations

2 sites across 2 countries: Austria, Belgium