Back to resultsLateral Ankle Sprain Study
Primary Purpose
Lateral Ankle Sprain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Air Cast Stirrup Brace & High Tide Fracture Boot
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Ankle Sprain focused on measuring Lateral Ankle Sprin, Air Cast Stirrup Brace, High Tide Fracture Boot
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
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Air Cast Stirrup Brace
High Tide Fracture Boot
Arm Description
50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
50 patients will be randomly assigned to the High Tide Fracture Boot.
Outcomes
Primary Outcome Measures
Modified Karlsson Score
Ankle function score - range 0 to 100. Higher score is better ankle function.
Secondary Outcome Measures
Patient Satisfaction (Measured on a Visual Analog Scale)
Satisfaction on 0-10 scale with 10 being the best.
Full Information
NCT ID
NCT00761865
First Posted
September 29, 2008
Last Updated
August 3, 2015
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT00761865
Brief Title
Lateral Ankle Sprain Study
Official Title
Lateral Ankle Sprain Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Ankle Sprain
Keywords
Lateral Ankle Sprin, Air Cast Stirrup Brace, High Tide Fracture Boot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Air Cast Stirrup Brace
Arm Type
Active Comparator
Arm Description
50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
Arm Title
High Tide Fracture Boot
Arm Type
Active Comparator
Arm Description
50 patients will be randomly assigned to the High Tide Fracture Boot.
Intervention Type
Device
Intervention Name(s)
Air Cast Stirrup Brace & High Tide Fracture Boot
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Karlsson Score
Description
Ankle function score - range 0 to 100. Higher score is better ankle function.
Time Frame
2 weeks post-sprain
Secondary Outcome Measure Information:
Title
Patient Satisfaction (Measured on a Visual Analog Scale)
Description
Satisfaction on 0-10 scale with 10 being the best.
Time Frame
2 weeks post-sprain
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedict DiGiovanni, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lateral Ankle Sprain Study
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