Lateral Ankle Sprain Study

NCT ID: NCT00761865

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-12-31

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

Conditions

Lateral Ankle Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Air Cast Stirrup Brace

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

Group Type: ACTIVE_COMPARATOR

Air Cast Stirrup Brace & High Tide Fracture Boot

Intervention Type: DEVICE

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.

High Tide Fracture Boot

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

Group Type: ACTIVE_COMPARATOR

Air Cast Stirrup Brace & High Tide Fracture Boot

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Benedict Digiovanni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benedict DiGiovanni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

23552

Identifier Type: -

Identifier Source: org_study_id