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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02382991
• Date of registration: 25/02/2015
• Prospective Registration: Yes
• Primary sponsor: Otto Bock France SNC
• Public title: Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)
• Scientific title: Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation
• Date of first enrolment: March 2015
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02382991
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, France, Germany

Contacts

• Name: Gerard Chiesa, Physician
• Affiliation: Institut Robert Merle d'Aubigné - 2 rue du Parc 94460 Valenton - France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amputation of Hip and Thigh, Level Unspecified

Intervention(s)

Device: 3C60-NMPK

Device: NMPK-3C60

Primary Outcome(s)

Timed Get Up and Go (TGUG) [Time Frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK]

Secondary Outcome(s)

Number of Falls [Time Frame: Measurement will be performed at 1 month with both devices]

SF-36v2™ Health Survey [Time Frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK]

Locomotor Capabilities Index (LCI-5) [Time Frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK]

QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version) [Time Frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK]

Use of Walking Aids [Time Frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK]

Secondary ID(s)

2014-A00754-43

20PT002-FR-01-0614

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02382991