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


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Lateral Ankle Sprain Study - NCT00761865-14642 (Clinical Trial 243735)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy243735.aspx

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City:

Rochester

State:

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 16, 2010
Modifications to this listing:		Only selected fields are shown, please use the link above to view all information about this clinical trial.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


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