Study Stopped
low enrollment
Lateral Ankle Sprain Study
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
August 7, 2015
CompletedAugust 7, 2015
August 1, 2015
3.2 years
September 29, 2008
December 3, 2013
August 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Karlsson Score
Ankle function score - range 0 to 100. Higher score is better ankle function.
2 weeks post-sprain
Secondary Outcomes (1)
Patient Satisfaction (Measured on a Visual Analog Scale)
2 weeks post-sprain
Study Arms (2)
Air Cast Stirrup Brace
ACTIVE COMPARATOR50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
High Tide Fracture Boot
ACTIVE COMPARATOR50 patients will be randomly assigned to the High Tide Fracture Boot.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18 \& Over
- Lateral Ankle Sprain (Grade II or III) presenting within 48 hours of initial injury without prior treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Results Point of Contact
- Title
- Benedict DiGiovanni
- Organization
- University of Rochester
Study Officials
- PRINCIPAL INVESTIGATOR
Benedict DiGiovanni, MD
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 29, 2008
First Posted
September 30, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 7, 2015
Results First Posted
August 7, 2015
Record last verified: 2015-08