Lateral Ankle Sprain Study

Not Applicable

Terminated

• Conditions: Lateral Ankle Sprain
• Interventions: Device: Air Cast Stirrup Brace & High Tide Fracture Boot

• Registration Number: NCT00761865
• Lead Sponsor: University of Rochester

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

Study Timeline

• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Study Start: 2008-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-12-03
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-03
• Last Update Submitted: 2015-08-03
• Results First Posted: 2015-08-07
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air Cast Stirrup Brace	Air Cast Stirrup Brace & High Tide Fracture Boot	50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
High Tide Fracture Boot	Air Cast Stirrup Brace & High Tide Fracture Boot	50 patients will be randomly assigned to the High Tide Fracture Boot.

Primary Outcome Measures

Name	Time	Method
Modified Karlsson Score	2 weeks post-sprain	Ankle function score - range 0 to 100. Higher score is better ankle function.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction (Measured on a Visual Analog Scale)	2 weeks post-sprain	Satisfaction on 0-10 scale with 10 being the best.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States