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C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees

NCT02765035 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-10-14

Study results available
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Summary

The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.

Conditions

  • Lower Limb Amputation Above Knee (Injury)

Interventions

DEVICE

C-Leg 4

Microprocessor Controlled Knee

DEVICE

C-Leg 3

Microprocessor Controlled Knee

Sponsors & Collaborators

  • Otto Bock Healthcare Products GmbH

    lead INDUSTRY

Principal Investigators

  • Stephan Domayer, Prim.Dr. · Orthopedic Rehabilitation Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-05-30
Completion
2018-05-30

Countries

  • Austria
  • Belgium

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 NCT02765035 on ClinicalTrials.gov