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Lateral Ankle Sprain Study - NCT00761865-14642(Clinical Trial 243735)



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City:  Rochester
State:  
NY
Zip Code: 14642
Conditions: Later Ankle Sprain
Purpose: The purpose of this study is to compare the short term treatment outcome measures of the standard of care air cell stirrup brace to that of a high tide fracture boot in patients with lateral ankle sprains.
Study summary: 100 patients with Grade II-III lateral ankle sprains requiring crutches will be invited to participate. Patients will randomly be assigned to be treated with either the Air Cast Stirrup Brace (n=50) or the High Tide Fracture Boot (n=50). All patients will be given instructions to use the fracture boot or air cell brace at all times of ambulatory activity until follow-up and to use NSAIDS as needed. At their 2 week post-sprain follow-up the following outcomes measures will be assessed: Modified Karlsson score (disease specific survey) Pain VAS Patient satisfaction with treatment VAS SMFA (general health measure) Ability to walk without crutches
Criteria: Inclusion Criteria: - Age 18 & Over - Lateral Ankle Sprain (Grade II or III) presenting within 48 hours of initial injury without prior treatment Exclusion Criteria: - Patients less than 18 years old - Those not able to give consent - Women who are pregnant or are expecting to become pregnant - > 48 hrs from injury at time of presentation - Prior treatment for injury - Fracture at time of current ankle injury or previous ankle fracture - Deltoid ligament injuries - Other orthopaedic injuries at time of presentation - Intoxication - Workman's Compensation injury - Mental Illness - Dementia
Study is available at: University of Rochester
Rochester, NY 14642
United States

Primary Contact:
Nancy Hibsch, BS
Email: Nancy_Hibsch@urmc.rochester.edu
Phone: 585-276-2577

Secondary Contact:
Nancy Hibsch, BS
Email: Nancy_Hibsch@urmc.rochester.edu
Phone: (585) 341-9304
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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