Elbow Fracture Clinical Trial
Official title:
Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations
The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.
Fractures and dislocations about the elbow are high energy injuries which are often
comminuted and associated with extensive soft tissue damage and are very difficult to treat.
The most problematic complication for these fractures is the potential development of a
cosmetic defect and functional disability due to the loss of 20 degrees to 30 degrees of
terminal extension of the elbow. It has been found imperative that early motion and physical
therapy be implemented to help produce the best results in terms of a patient's range of
motion and decreases secondary surgeries.
We intend to examine a group of patients with distal humerus and elbow fracture/dislocations
who use static stretching braces along with physical therapy within 3 weeks after surgery,
in contrast to physical therapy treatment alone after surgery. The static stretching brace
group will have a small electronic circuit attached to the brace that will record patient's
usage.
Improvement of patient's overall functional outcome will also be measured by a standard
functional outcome instrument, the Disabilities of Arm, Shoulder and Hand (DASH) form. The
DASH Form is a standard functional outcome instrument specific to upper extremity injuries.
In addition, a more general measure, the Visual Analog Scale (VAS), will be used to assess
pain.
The use of the static motion brace may help eliminate the necessity of additional
treatments, saving both pain and suffering, as well as monetary costs for the patient, while
simultaneously producing a better long term functional and cosmetic outcome.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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