Status:
COMPLETED
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
Lead Sponsor:
Jason Highsmith
Collaborating Sponsors:
Otto Bock Healthcare
Florida High Tech Corridor Council
Conditions:
Other and Unspecified Complications of Amputation Stump
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Unilateral transfemoral or knee-disarticulation amputee
- 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:
- History of chronic skin breakdown on the residual limb
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01473992
Start Date
January 1 2011
End Date
February 1 2013
Last Update
December 12 2023
Active Locations (1)
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1
University of South Florida
Tampa, Florida, United States, 33612