Lateral Ankle Sprain Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lateral Ankle Sprain
- Sponsor
- University of Rochester
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Modified Karlsson Score
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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
Investigators
Benedict Digiovanni
Principal Investigator
University of Rochester
Eligibility 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
Outcomes
Primary Outcomes
Modified Karlsson Score
Time Frame: 2 weeks post-sprain
Ankle function score - range 0 to 100. Higher score is better ankle function.
Secondary Outcomes
- Patient Satisfaction (Measured on a Visual Analog Scale)(2 weeks post-sprain)