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Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)
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Purpose
| Condition | Intervention |
|---|---|
| Upper Extremity Fracture Upper Extremity Dislocation Fractures, Comminuted Elbow Fracture Elbow Dislocation | Device: JAS Brace |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations |
- 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 )
| Enrollment: | 17 |
| Study Start Date: | September 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Names:
|
|
No Intervention: PT Only Group
No brace is used
|
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 (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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older
- Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation
- Agrees to participate and signs informed consent
- English Speaking (outcome questionnaires are validated for English only)
Exclusion Criteria:
- Less than 18 years of age
- Closed Head Injury
- Burn Injuries
- Ipsilateral upper extremity fracture(s) requiring surgery
- Nonunion of prior distal humerus fracture or fracture dislocation
- Type 3 open distal humerus fracture dislocation
- Insufficient fracture fixation to allow early range of motion
- Transient population with no fixed address
- Not willing to sign informed consent
- Does not speak English
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | William Obremskey, Associate Professor, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00580866 History of Changes |
| Other Study ID Numbers: |
051196 |
| Study First Received: | December 19, 2007 |
| Results First Received: | November 10, 2015 |
| Last Updated: | July 22, 2016 |
Keywords provided by William Obremskey, Vanderbilt University:
|
Elbow Upper Extremity Fractures Distal Humerus |
Elbow Injuries Dislocations Peri-articular Elbow Injuries |
Additional relevant MeSH terms:
|
Fractures, Bone Dislocations Fractures, Comminuted Wounds and Injuries |
Polystyrene sulfonic acid Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 28, 2017