Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis

Jason Highsmith

Status: Completed

Conditions: Other and Unspecified Complications of Amputation Stump

Treatments: Device: Otto Bock C-Leg; Device: Otto Bock Genium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01473992

6140101200

Details and patient eligibility

About

The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Unilateral transfemoral or knee-disarticulation amputee
• 18 to 85 years of age
• K3 (variable cadence and community) ambulators;
• Current use of and experience with the C-Leg for at least 1 year
• Ability to descend stairs and hills without caregiver and assistive devices
• Be able to independently provide informed consent
• Be willing to comply with study procedures.

Exclusion criteria

• History of chronic skin breakdown on the residual limb
• Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
• Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
• Unwillingness/inability to follow instructions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Prosthetic knee 1 (Otto Bock C-Leg)

Active Comparator group

Description:

This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics).

Treatment:

Device: Otto Bock C-Leg

Prosthetic knee 2 (Otto Bock Genium)

Active Comparator group

Description:

This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance)

Treatment:

Device: Otto Bock Genium

Non-amputee controls

No Intervention group

Description:

This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.