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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00580866 |
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.
Condition | Intervention |
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Upper Extremity Fracture Upper Extremity Dislocation Fractures, Comminuted Elbow Fracture Elbow Dislocation |
Device: JAS Brace |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations |
Estimated Enrollment: | 50 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Brace Group: Active Comparator |
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.
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PT Only Group: No Intervention |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Vanderbilt University ( William T. Obremskey, MD, MPH ) |
Study ID Numbers: | 051196 |
Study First Received: | December 19, 2007 |
Last Updated: | June 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00580866 History of Changes |
Health Authority: | United States: Institutional Review Board |
Elbow Upper Extremity Fractures Distal Humerus |
Elbow Injuries Dislocations Peri-articular Elbow Injuries |
Dislocations Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Fractures, Comminuted |
Dislocations Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Fractures, Comminuted |