Lateral Ankle Sprain Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Lateral Ankle Sprain Study

Conditions
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Lateral Ankle Sprain

Intervention / Treatment
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* Device: Air Cast Stirrup Brace & High Tide Fracture Boot


Participation Criteria
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Eligibility Criteria
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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

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Air Cast Stirrup Brace<br>50 patients will be randomly assigned to receive the Air Cast Stirrup Brace. | Device: Air Cast Stirrup Brace & High Tide Fracture Boot<br>* Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.<br>|
| Active Comparator: High Tide Fracture Boot<br>50 patients will be randomly assigned to the High Tide Fracture Boot. | Device: Air Cast Stirrup Brace & High Tide Fracture Boot<br>* Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Karlsson Score | Ankle function score - range 0 to 100. Higher score is better ankle function. | 2 weeks post-sprain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction (Measured on a Visual Analog Scale) | Satisfaction on 0-10 scale with 10 being the best. | 2 weeks post-sprain | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral Ankle Sprin, Air Cast Stirrup Brace, High Tide Fracture Boot