NCT00761865

Lateral Ankle Sprain Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lateral Ankle Sprain

Interventions

Type	Name	Description
DEVICE	Air Cast Stirrup Brace & High Tide Fracture Boot	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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-09-30
• Last updated: 2015-08-07
• Results posted: 2015-08-07

Locations

1 site across 1 country: United States