Lateral Ankle Sprain Study

August 3, 2015 updated by: Benedict Digiovanni, University of Rochester
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Air Cast Stirrup Brace
50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
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.
ACTIVE_COMPARATOR: High Tide Fracture Boot
50 patients will be randomly assigned to the High Tide Fracture Boot.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Karlsson Score
Time Frame: 2 weeks post-sprain
Ankle function score - range 0 to 100. Higher score is better ankle function.
2 weeks post-sprain

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction (Measured on a Visual Analog Scale)
Time Frame: 2 weeks post-sprain
Satisfaction on 0-10 scale with 10 being the best.
2 weeks post-sprain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Benedict DiGiovanni, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (ESTIMATE)

September 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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