An interventional study of Air Cast Stirrup Brace & High Tide Fracture Boot in Lateral Ankle Sprain, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-07.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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
217 studies on the registry are indexed under Sprains and Strains; 44 are open to participants now.
This study's enrollment of 34 is below the median of 60 across 166 interventional studies indexed under Sprains and Strains.
Browse Sprains and Strains studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
Device: Air Cast Stirrup Brace & 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.
Modified Karlsson Score
Ankle function score - range 0 to 100. Higher score is better ankle function.
Time frame: 2 weeks post-sprain
Patient Satisfaction (Measured on a Visual Analog Scale)
Satisfaction on 0-10 scale with 10 being the best.
Time frame: 2 weeks post-sprain
| Milestone | Air Cast Stirrup Brace | High Tide Fracture Boot |
|---|---|---|
| Started | 16 | 18 |
| Completed | 8 | 11 |
| Not completed | 8 | 7 |
| Withdrew: Lost to follow-up | 8 | 7 |
Ankle function score - range 0 to 100. Higher score is better ankle function.
| units on a scale | Air Cast Stirrup Brace | High Tide Fracture Boot |
|---|---|---|
| Modified Karlsson Score | 67 (33 to 92) | 73 (41 to 95) |
Satisfaction on 0-10 scale with 10 being the best.
| units on a scale | Air Cast Stirrup Brace | High Tide Fracture Boot |
|---|---|---|
| Patient Satisfaction (Measured on a Visual Analog Scale) | 7 (2 to 9) | 8 (2 to 10) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Air Cast Stirrup Brace | — | 0/16 (0%) | 0/16 (0%) |
| High Tide Fracture Boot | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Air Cast Stirrup Brace | High Tide Fracture Boot | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 18 | 34 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Air Cast Stirrup Brace | High Tide Fracture Boot | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 8 | 13 | 21 |
This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Rochester