Lateral Ankle Sprain Study

University of Rochester

Status: Terminated

Conditions: Lateral Ankle Sprain

Treatments: Device: Air Cast Stirrup Brace & High Tide Fracture Boot

Study type: Interventional

Funder types: Other

Identifiers

NCT00761865

23552

Details and patient eligibility

About

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.

Full 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

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Air Cast Stirrup Brace

Active Comparator group

Description:

50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.

Treatment:

Device: Air Cast Stirrup Brace & High Tide Fracture Boot

High Tide Fracture Boot

Active Comparator group

Description:

50 patients will be randomly assigned to the High Tide Fracture Boot.

Treatment:

Device: Air Cast Stirrup Brace & High Tide Fracture Boot