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

NCT02382991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-10-23

Study results available
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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.

Conditions

  • Amputation of Hip and Thigh, Level Unspecified

Interventions

DEVICE

3C60-NMPK

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

DEVICE

NMPK-3C60

1 month with NMPK - 3 months with 3C60

Sponsors & Collaborators

  • Otto Bock France SNC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Austria
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02382991 on ClinicalTrials.gov