Lateral Ankle Sprain Study
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | December 2011 |
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.
standard of care air cell stirrup brace to that of a high tide fracture boot in patients
with lateral ankle sprains.
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
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
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
We found this trial at
1
site
University of Rochester The University of Rochester is one of the country's top-tier research universities....
Click here to add this to my saved trials
