Elbow Fracture Clinical Trial
— JASOfficial title:
Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations
Verified date | June 2014 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument. | 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively | No |
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