Trial Outcomes & Findings for Lateral Ankle Sprain Study (NCT NCT00761865)

Results Overview

Ankle function score - range 0 to 100. Higher score is better ankle function.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

2 weeks post-sprain

Results posted on

2015-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	16	18
Overall Study COMPLETED	8	11
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	8	7

Baseline Characteristics

Lateral Ankle Sprain Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Air Cast Stirrup Brace n=16 Participants 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 n=18 Participants 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 n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks post-sprain

Ankle function score - range 0 to 100. Higher score is better ankle function.

Outcome measures

Outcome measures
Measure	Air Cast Stirrup Brace n=16 Participants 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 n=18 Participants 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.
Modified Karlsson Score	67 units on a scale Interval 33.0 to 92.0	73 units on a scale Interval 41.0 to 95.0

SECONDARY outcome

Timeframe: 2 weeks post-sprain

Satisfaction on 0-10 scale with 10 being the best.

Outcome measures

Outcome measures
Measure	Air Cast Stirrup Brace n=16 Participants 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 n=18 Participants 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.
Patient Satisfaction (Measured on a Visual Analog Scale)	7 units on a scale Interval 2.0 to 9.0	8 units on a scale Interval 2.0 to 10.0

Adverse Events

Air Cast Stirrup Brace

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Tide Fracture Boot

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benedict DiGiovanni

University of Rochester

Phone: 5852731611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place