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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 19, 2007 | ||||
| Last Updated Date | June 5, 2009 | ||||
| Start Date ICMJE | September 2006 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00580866 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Progressive Splinting Status Post Elbow Fractures and Dislocations | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | 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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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Basic Science, Non-Randomized, Open Label, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: JAS Brace | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | July 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00580866 | ||||
| Responsible Party | William T. Obremskey, MD, MPH, Vanderbilt University | ||||
| Study ID Numbers ICMJE | 051196 | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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