Lateral Ankle Sprain Study

Lateral Ankle Sprain Clinical Trial

Official title: Lateral Ankle Sprain Study

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Lateral Ankle Sprain

• NCT number: NCT00761865
• Study type: Interventional
• Source: University of Rochester
• Status: Terminated
• Phase: N/A
• Start date: October 2008
• Completion date: December 2011