Lateral Ankle SprainNCT00761865
Lateral Ankle Sprain Study
A study testing Air Cast Stirrup Brace & High Tide Fracture Boot in people with Lateral Ankle Sprain, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Ankle Sprain
- What is being tested?
- Air Cast Stirrup Brace & High Tide Fracture Boot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 \& Over
- Lateral Ankle Sprain (Grade II or III) presenting within 48 hours of initial injury without prior treatment
Who cannot join
- 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
Show all 12Show fewer
- Deltoid ligament injuries
- Other orthopaedic injuries at time of presentation
- Intoxication
- Workman's Compensation injury
- Mental Illness
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Lateral Ankle Sprain
- Being tested
- Air Cast Stirrup Brace & High Tide Fracture Boot
- Keywords
- Lateral Ankle Sprin, Air Cast Stirrup Brace, High Tide Fracture Boot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Cast Stirrup Brace & High Tide Fracture BootDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Air Cast Stirrup Brace | Active comparator | 50 patients will be randomly assigned to receive the Air Cast Stirrup Brace. Receives: Device: Air Cast Stirrup Brace & High Tide Fracture Boot |
| High Tide Fracture Boot | Active comparator | 50 patients will be randomly assigned to the High Tide Fracture Boot. Receives: Device: Air Cast Stirrup Brace & High Tide Fracture Boot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Karlsson Score
Ankle function score - range 0 to 100. Higher score is better ankle function.
Measured: 2 weeks post-sprain
Secondary outcomes (1)
Patient Satisfaction (Measured on a Visual Analog Scale)
Satisfaction on 0-10 scale with 10 being the best.
Measured: 2 weeks post-sprain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lateral Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedict Digiovanni, University of Rochester
- Investigators
- Benedict DiGiovanni, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761865
- Sponsor's protocol ID
- 23552
- Status last verified
- Aug 2015
- First submitted
- 29 Sep 2008
- Last updated
- 7 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Ankle Sprain Study
- ClinicalTrials.gov ID
- NCT00761865
- Acronym / sponsor ID
- 23552
- Conditions
- Lateral Ankle Sprain
- Keywords
- Lateral Ankle Sprin, Air Cast Stirrup Brace, High Tide Fracture Boot
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 7 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air Cast Stirrup Brace | Active comparator | Device: Air Cast Stirrup Brace & High Tide Fracture Boot50 patients will be randomly assigned to receive the Air Cast Stirrup Brace. |
| High Tide Fracture Boot | Active comparator | Device: Air Cast Stirrup Brace & High Tide Fracture Boot50 patients will be randomly assigned to the High Tide Fracture Boot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 \& Over
- Lateral Ankle Sprain (Grade II or III) presenting within 48 hours of initial injury without prior treatment
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air Cast Stirrup Brace & High Tide Fracture BootSubjects 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. | Device | Air Cast Stirrup Brace, High Tide Fracture Boot |
Primary outcome
Modified Karlsson Score
Time frame: 2 weeks post-sprain
Ankle function score - range 0 to 100. Higher score is better ankle function.
1 secondary outcome
Patient Satisfaction (Measured on a Visual Analog Scale)
Time frame: 2 weeks post-sprain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lateral Ankle Sprain
Not yet recruiting
Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain
Ankle Sprains, Lateral Ankle Sprain
Recruiting
Mulligan Mobilization With Movement for Acute Lateral Ankle Sprains
Lateral Ankle Sprain
Recruiting
Dynamic Neuromuscular Stability Exercises With and Without Rhythmic Auditory Stimulation in Lateral Ankle Sprain
Ankle Sprain, Lateral Ankle Sprain
RecruitingObservational study
Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study
Ankle Sprain, Hypermobility, Joint
Not yet recruitingObservational study
Distinct Directional Postural Stability Deficits Across Lower Limb Musculoskeletal Disorders
Ankle Sprains, Patellofemoral Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benedict DiGiovanni, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Cast Stirrup Brace & High Tide Fracture Boot in people with Lateral Ankle Sprain, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Karlsson Score (time frame: 2 weeks post-sprain). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.