Lateral Ankle Sprain Study

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00761865
First received: September 29, 2008
Last updated: August 30, 2013
Last verified: August 2013

September 29, 2008
August 30, 2013
October 2008
December 2011   (final data collection date for primary outcome measure)
Modified Karlsson Score, Pain Visual Analog Scale & SMFA [ Time Frame: 2 weeks post-sprain ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00761865 on ClinicalTrials.gov Archive Site
Patient Satisfaction (measured on a Visual Analog Scale) & Ability to walk without crutches [ Time Frame: 2 weeks post-sprain ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lateral Ankle Sprain Study
Lateral Ankle Sprain 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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lateral Ankle Sprain
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: Air Cast Stirrup Brace
    50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
    Intervention: Device: Air Cast Stirrup Brace & High Tide Fracture Boot
  • Active Comparator: High Tide Fracture Boot
    50 patients will be randomly assigned to the High Tide Fracture Boot.
    Intervention: Device: Air Cast Stirrup Brace & High Tide Fracture Boot
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
May 2013
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00761865
23552
No
University of Rochester
University of Rochester
Not Provided
Principal Investigator: Benedict DiGiovanni, MD University of Rochester
University of Rochester
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP