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Lateral Ankle Sprain Study

This study is currently recruiting participants.
Verified September 2012 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00761865
First received: September 29, 2008
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Lateral Ankle Sprain
 Device: Air Cast Stirrup Brace & High Tide Fracture Boot

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lateral Ankle Sprain Study

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Modified Karlsson Score, Pain Visual Analog Scale & SMFA [ Time Frame: 2 weeks post-sprain ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Satisfaction (measured on a Visual Analog Scale) & Ability to walk without crutches [ Time Frame: 2 weeks post-sprain ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761865

Contacts
Contact: Allison McIntyre, MPH (585) 341-9304 Allisonw_mcintyre@urmc.rochester.edu
Contact: Sarah Neu, BS 585-341-9305 sarah_neu@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Allison W McIntyre, MPH     585-341-9304     AllisonW_McIntyre@urmc.rochester.edu    
Principal Investigator: Benedict DiGiovanni, MD            
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Benedict DiGiovanni, MD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00761865     History of Changes
Other Study ID Numbers: 23552
Study First Received: September 29, 2008
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013