Lateral Ankle Sprain Study - Full Text View

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00761865

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

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Lateral Ankle Sprain Study

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:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Air Cast Stirrup Brace: Active Comparator 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.
High Tide Fracture Boot: Active Comparator 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: Nancy Hibsch, BS

(585) 341-9304

Nancy_Hibsch@urmc.rochester.edu

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Nancy Hibsch, BS 585-276-2577 Nancy_Hibsch@urmc.rochester.edu
Contact: Kelly Unsworth, MS (585) 273-1465 Kelly_Unsworth@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 ( Benedict DiGiovanni, MD )
Study ID Numbers:	23552
Study First Received:	September 29, 2008
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00761865 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Lateral Ankle Sprin
Air Cast Stirrup Brace
High Tide Fracture Boot

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Sprains and Strains

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Sprains and Strains

ClinicalTrials.gov processed this record on May 07, 2009