Lateral Ankle Sprain Study

Lateral Ankle Sprain Clinical Trial

Official title:

Lateral Ankle Sprain Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00761865
• Other study ID #: 23552
• Status: Terminated
• Phase: N/A
• First received: September 29, 2008
• Last updated: August 3, 2015
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Lateral Ankle Sprain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Karlsson Score	Ankle function score - range 0 to 100. Higher score is better ankle function.	2 weeks post-sprain	No
Secondary	Patient Satisfaction (Measured on a Visual Analog Scale)	Satisfaction on 0-10 scale with 10 being the best.	2 weeks post-sprain	No