Southern Bone & Joint Study - Brimless Sockets

Completed · Phase 3

Conditions studied: Socket Designs of Transfemoral Amputees.

In brief

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 care using our designated outcome measures.

Key facts

Study ID

NCT01416129

Run by

University of South Florida

People needed

10

Starts

2010-10-01

Expected to finish

2011-10-01

Last updated by the study team

2014-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of South Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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