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Lateral Ankle Sprain Study

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ClinicalTrials.gov Identifier: NCT00761865
Recruitment Status : Terminated (low enrollment)
First Posted : September 30, 2008
Results First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Benedict Digiovanni, University of Rochester

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.

Condition or disease Intervention/treatment
Lateral Ankle Sprain Device: Air Cast Stirrup Brace & High Tide Fracture Boot

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lateral Ankle Sprain Study
Study Start Date : October 2008
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Air Cast Stirrup Brace
50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
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.
Active Comparator: 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.



Primary Outcome Measures :
  1. Modified Karlsson Score [ Time Frame: 2 weeks post-sprain ]
    Ankle function score - range 0 to 100. Higher score is better ankle function.


Secondary Outcome Measures :
  1. Patient Satisfaction (Measured on a Visual Analog Scale) [ Time Frame: 2 weeks post-sprain ]
    Satisfaction on 0-10 scale with 10 being the best.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761865


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Benedict DiGiovanni, MD University of Rochester

Responsible Party: Benedict Digiovanni, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00761865     History of Changes
Other Study ID Numbers: 23552
First Posted: September 30, 2008    Key Record Dates
Results First Posted: August 7, 2015
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Benedict Digiovanni, University of Rochester:
Lateral Ankle Sprin
Air Cast Stirrup Brace
High Tide Fracture Boot

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries