Status:
COMPLETED
Southern Bone & Joint Study - Brimless Sockets
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Southern Bone & Joint Specialists, P.A.
Conditions:
Socket Designs of Transfemoral Amputees.
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of ...
Eligibility Criteria
Inclusion
- Unilateral transfemoral or knee-disarticulation amputee
- 18 to 85 years of age
- K3 (variable cadence and community) ambulators;
- Be able to independently provide informed consent
- Be willing to comply with study procedures.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01416129
Start Date
October 1 2010
End Date
October 1 2011
Last Update
June 2 2014
Active Locations (1)
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1
University of South Florida
Tampa, Florida, United States, 33612