Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
NCT ID: NCT01473992
Last Updated: 2023-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2011-01-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Prosthetic knee 1 (Otto Bock C-Leg)
This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics).
Otto Bock C-Leg
Amputees' preferred prosthetic knee.
Prosthetic knee 2 (Otto Bock Genium)
This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance)
Otto Bock Genium
Study knee.
Non-amputee controls
This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No interventions assigned to this group
Interventions
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Otto Bock C-Leg
Amputees' preferred prosthetic knee.
Otto Bock Genium
Study knee.
Eligibility Criteria
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Inclusion Criteria
* 18 to 85 years of age
* K3 (variable cadence and community) ambulators;
* Current use of and experience with the C-Leg for at least 1 year
* Ability to descend stairs and hills without caregiver and assistive devices
* Be able to independently provide informed consent
* Be willing to comply with study procedures.
Exclusion Criteria
* Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
* Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
* Unwillingness/inability to follow instructions
18 Years
85 Years
ALL
Yes
Sponsors
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Otto Bock Healthcare
INDUSTRY
Florida High Tech Corridor Council
OTHER
Jason Highsmith
OTHER
Responsible Party
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Jason Highsmith
Principal Investigator
Principal Investigators
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M. Jason Highsmith, PT,DPT,CP
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Other Identifiers
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6140101200
Identifier Type: -
Identifier Source: org_study_id