Progressive Splinting Status Post Elbow Fractures and Dislocations

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Upper Extremity Fracture, Upper Extremity Dislocation, Fractures, Comminuted, Elbow Fracture, Elbow Dislocation

Intervention / Treatment
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* Device: JAS Brace


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Joint Active Systems Brace (JAS Brace)<br>Elbow is placed in a brace to apply an extension force | Device: JAS Brace<br>* 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.<br>* Other names: Static Progressive Stretching Brace;|
| No Intervention: PT Only Group<br>No brace is used | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elbow ROM at 12 Months | The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion. | 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand (DASH) Score | 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 ) | 12 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dislocations, Elbow, Upper Extremity Fractures, Distal Humerus, Elbow Injuries, Peri-articular Elbow Injuries