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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air Cast Stirrup Brace | Active Comparator | 50 patients will be randomly assigned to receive the Air Cast Stirrup Brace. |
|
| High Tide Fracture Boot | Active Comparator | 50 patients will be randomly assigned to the High Tide Fracture Boot. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air Cast Stirrup Brace & High Tide Fracture Boot | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Karlsson Score | Ankle function score - range 0 to 100. Higher score is better ankle function. | 2 weeks post-sprain |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction (Measured on a Visual Analog Scale) | Satisfaction on 0-10 scale with 10 being the best. | 2 weeks post-sprain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benedict DiGiovanni, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Air Cast Stirrup Brace | 50 patients will be randomly assigned to receive the Air Cast Stirrup Brace. 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. |
| FG001 | High Tide Fracture Boot | 50 patients will be randomly assigned to the High Tide Fracture Boot. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Air Cast Stirrup Brace | 50 patients will be randomly assigned to receive the Air Cast Stirrup Brace. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Karlsson Score | Ankle function score - range 0 to 100. Higher score is better ankle function. | Posted | Mean | Full Range | units on a scale | 2 weeks post-sprain |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Air Cast Stirrup Brace | 50 patients will be randomly assigned to receive the Air Cast Stirrup Brace. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benedict DiGiovanni | University of Rochester | 5852731611 | benedict_digiovanni@urmc.rochester.edu |
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| BG001 | High Tide Fracture Boot | 50 patients will be randomly assigned to the High Tide Fracture Boot. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Patient Satisfaction (Measured on a Visual Analog Scale) | Satisfaction on 0-10 scale with 10 being the best. | Posted | Mean | Full Range | units on a scale | 2 weeks post-sprain |
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | High Tide Fracture Boot | 50 patients will be randomly assigned to the High Tide Fracture Boot. 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. | 0 | 18 | 0 | 18 |
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