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

Lower Limb Amputation Above Knee (Injury) Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Lower Limb Amputation Above Knee (Injury)
Clinical Trial Details
NCT number NCT02765035
Study type Interventional
Source Otto Bock Healthcare Products GmbH
Contact
Status Completed
Phase N/A
Start date April 2016
Completion date May 30, 2018
View Details
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