Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)

Otto Bock Healthcare (Ottobock)

Status: Completed

Conditions: Amputation of Hip and Thigh, Level Unspecified

Treatments: Device: NMPK-3C60; Device: 3C60-NMPK

Study type: Interventional

Funder types: Industry

Identifiers

NCT02382991

20PT002-FR-01-0614

2014-A00754-43 (Registry Identifier)

Details and patient eligibility

About

Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling.

The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.

Full description

The patient will be evaluated after one month of using his/her usual non micropressor controlled knee joint (NMPK). After fitting of the 3C60, the patient will undergo at least five rehabilitation sessions, adapted to his/her individual needs, so that he/she knows how to use the device and is ready to go along with the planned testing.

After the trial with the 3C60 knee, the patient will again be fitted with his/her non microprocessor controlled knee joint (NMPK) and will be required to undergo one rehabilitation session to regain his/her walking abilities.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Person with leg amputation above knee or knee disarticulation with stabilized residual limb
• Person who are currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee
• Person with a high risk of falling, which is defined as a TGUG test score of more than 19 seconds
• Person who moves around within buildings other than one's residence, such as moving around other people's homes, other private buildings, community and private or public buildings and enclosed areas, moving throughout all parts of buildings and enclosed areas, between floors, inside, outside and around buildings, both public and private
• Person who moves around outside the home and other buildings, such as walking and moving around close to or far from one's home and other buildings, without the use of transportation, public or private, such as walking for short or long distances around a town or village, walking or moving down streets in the neighbourhood, town, village or city; moving between cities and further distances, without using transportation
• Person with a daily walking distance greater than 300 m

Exclusion criteria

• Persons using underarm crutches or walkers
• Persons under 18 years of age
• Persons who weigh more than 125 kg
• Pregnant women
• Persons in an emergency situation
• Persons who cannot personally provide their consent
• Persons who are not available to follow the entire study protocol

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

NMPK-3C60

Other group

Description:

D0 + 30 days: evaluation with the non-microprocessor knee. D1 + 90 days: evaluation with the 3C60 knee.

Treatment:

Device: 3C60-NMPK

3C60-NMPK

Other group

Description:

D0 + 90 days: evaluation with the 3C60 knee. A period of 10 days of "wash out". D1 + 30 days: evaluation with the non-microprocessor knee.

Treatment:

Device: NMPK-3C60