Lateral Ankle Sprain Study

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
Benedict Digiovanni, University of Rochester
ClinicalTrials.gov Identifier:
NCT00761865
First received: September 29, 2008
Last updated: August 3, 2015
Last verified: August 2015
Results First Received: December 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lateral Ankle Sprain
Intervention: Device: Air Cast Stirrup Brace & High Tide Fracture Boot

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Air Cast Stirrup Brace

50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.

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.

High Tide Fracture Boot

50 patients will be randomly assigned to the High Tide Fracture Boot.

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.


Participant Flow:   Overall Study
    Air Cast Stirrup Brace     High Tide Fracture Boot  
STARTED     16     18  
COMPLETED     8     11  
NOT COMPLETED     8     7  
Lost to Follow-up                 8                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Air Cast Stirrup Brace

50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.

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.

High Tide Fracture Boot

50 patients will be randomly assigned to the High Tide Fracture Boot.

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.

Total Total of all reporting groups

Baseline Measures
    Air Cast Stirrup Brace     High Tide Fracture Boot     Total  
Number of Participants  
[units: participants]
  16     18     34  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     18     34  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     8     5     13  
Male     8     13     21  



  Outcome Measures
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1.  Primary:   Modified Karlsson Score   [ Time Frame: 2 weeks post-sprain ]

2.  Secondary:   Patient Satisfaction (Measured on a Visual Analog Scale)   [ Time Frame: 2 weeks post-sprain ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Benedict DiGiovanni
Organization: University of Rochester
phone: 5852731611
e-mail: benedict_digiovanni@urmc.rochester.edu


No publications provided


Responsible Party: Benedict Digiovanni, University of Rochester
ClinicalTrials.gov Identifier: NCT00761865     History of Changes
Other Study ID Numbers: 23552
Study First Received: September 29, 2008
Results First Received: December 3, 2013
Last Updated: August 3, 2015
Health Authority: United States: Institutional Review Board