Lateral Ankle Sprain Study - Full Text View

Sponsor:	University of Rochester
Information provided by (Responsible Party):	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

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 2012
Estimated Primary Completion Date:	August 2012 (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, BS	(585) 341-9304	Allisonw_mcintyre@urmc.rochester.edu
Contact: Sara Defendorf, BS	585-341-9305	sara_defendorf@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
Contact: Sara Defendorf, BS (585) 341-9305 sara_defendorf@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:	January 25, 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 February 09, 2012