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

NCT ID: NCT02382991

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-11-30

Brief Summary

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.

Detailed 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.

Conditions

Amputation of Hip and Thigh, Level Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

NMPK-3C60

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

Group Type: OTHER

3C60-NMPK

Intervention Type: DEVICE

3 months with 3C60 - 10 days wash out - 1 month with NMPK

3C60-NMPK

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.

Group Type: OTHER

NMPK-3C60

Intervention Type: DEVICE

1 month with NMPK - 3 months with 3C60

Interventions

3C60-NMPK

3 months with 3C60 - 10 days wash out - 1 month with NMPK

Intervention Type: DEVICE

NMPK-3C60

1 month with NMPK - 3 months with 3C60

Intervention Type: DEVICE

Other Intervention Names

Mechanical knee joint; C-LEG COMPACT 2; KENEVO

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Otto Bock France SNC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Chiesa, Physician

Role: PRINCIPAL_INVESTIGATOR

Institut Robert Merle d'Aubigné - 2 rue du Parc 94460 Valenton - France

Locations

Sonderkrankenanstalt Zicksee

Sankt Andrä am Zicksee, , Austria

CRMPR "Les Herbiers"

Bois-Guillaume, , France

Hôpital d'instruction des Armées Percy

Clamart, , France

Centre Hospitalier de Cornouaille Concarneau

Concarneau, , France

Centre de réadaptation de Coubert

Coubert, , France

CHU de Grenoble Hôpital Sud

Échirolles, , France

Clinique Chantecler

Marseille, , France

Institut Régional de Médecine Physique et de Réadaptation

Nancy, , France

Institut National des Invalides

Paris, , France

Hôpital Léopold Belan

Paris, , France

Pôle Saint-Hélier

Rennes, , France

Hôpital privé de l'Est Lyonnais

Saint-Priest, , France

Centre l'Adapt Thionis

Thionville, , France

Institut Robert Merle d'Aubigné

Valenton, , France

Universitätsmedizin Göttingen

Göttingen, , Germany

Countries

Austria; France; Germany

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Other Identifiers

2014-A00754-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

20PT002-FR-01-0614

Identifier Type: -

Identifier Source: org_study_id