Lateral Ankle Sprain
Conditions
Keywords
Lateral Ankle Sprin, Air Cast Stirrup Brace, High Tide Fracture Boot
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
Interventions
DEVICEAir 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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Karlsson Score | 2 weeks post-sprain | Ankle function score - range 0 to 100. Higher score is better ankle function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction (Measured on a Visual Analog Scale) | 2 weeks post-sprain | Satisfaction on 0-10 scale with 10 being the best. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 18 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 7 |
Baseline characteristics
| Characteristic | Air Cast Stirrup Brace | High Tide Fracture Boot | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
Primary
Modified Karlsson Score
Ankle function score - range 0 to 100. Higher score is better ankle function.
Time frame: 2 weeks post-sprain
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Air Cast Stirrup Brace | Modified Karlsson Score | 67 units on a scale |
| High Tide Fracture Boot | Modified Karlsson Score | 73 units on a scale |
Secondary
Patient Satisfaction (Measured on a Visual Analog Scale)
Satisfaction on 0-10 scale with 10 being the best.
Time frame: 2 weeks post-sprain
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Air Cast Stirrup Brace | Patient Satisfaction (Measured on a Visual Analog Scale) | 7 units on a scale |
| High Tide Fracture Boot | Patient Satisfaction (Measured on a Visual Analog Scale) | 8 units on a scale |