Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)
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|ClinicalTrials.gov Identifier: NCT00580866|
Recruitment Status : Terminated (low accrual)
First Posted : December 27, 2007
Results First Posted : September 7, 2016
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Upper Extremity Fracture Upper Extremity Dislocation Fractures, Comminuted Elbow Fracture Elbow Dislocation||Device: JAS Brace||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Experimental: Joint Active Systems Brace (JAS Brace)
Elbow is placed in a brace to apply an extension force
Device: JAS Brace
For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
No Intervention: PT Only Group
No brace is used
- 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.
- 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 )
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580866
|United States, Tennessee|
|Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-8774|
|Principal Investigator:||William T Obremskey, MD, MPH||Vanderbilt University Medical Center|