Clinical Trial: Progressive Splinting Status Post Elbow Fractures and Dislocations

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations

Brief Summary: 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.

Detailed Summary:

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 (PT) 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.


Sponsor: Vanderbilt University

Current Primary Outcome: Elbow ROM at 12 Months [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively ]

The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.


Original Primary Outcome: The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion. [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively ]

Current Secondary Outcome: Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 12 months post-operatively ]

Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )


Original Secondary Outcome: Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument. [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively ]

Information By: Vanderbilt University

Dates:
Date Received: December 19, 2007
Date Started: September 2006
Date Completion:
Last Updated: July 22, 2016
Last Verified: July 2016