Trial Outcomes & Findings for Brace Versus Casting in Pediatric Low Risk Ankle Fractures (NCT NCT00132964)

Results Overview

Activities Scale for Kids (ASKp) measured by a physiotherapist at 4 week visit and is a validated 38-questionnaire that targets activities of children. The minimal scores are 0 and maximum are 100. Higher score indicates higher function.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

111 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Immobilizaton Device Below Knee walking cast was placed on the ankle injury.	Immobilization Device Removable ankle brace was placed on the injured ankle.
Overall Study STARTED	54	57
Overall Study COMPLETED	50	54
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brace Versus Casting in Pediatric Low Risk Ankle Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immobilizaton Device n=54 Participants Below Knee walking cast	Immobilization Device n=57 Participants Removable ankle brace	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	54 Participants n=99 Participants	57 Participants n=107 Participants	111 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	10.55 years STANDARD_DEVIATION 2.91 • n=99 Participants	9.94 years STANDARD_DEVIATION 2.43 • n=107 Participants	10.2 years STANDARD_DEVIATION 2.62 • n=206 Participants
Sex: Female, Male Female	25 Participants n=99 Participants	25 Participants n=107 Participants	50 Participants n=206 Participants
Sex: Female, Male Male	29 Participants n=99 Participants	32 Participants n=107 Participants	61 Participants n=206 Participants
Region of Enrollment Canada	54 participants n=99 Participants	57 participants n=107 Participants	111 participants n=206 Participants

PRIMARY outcome

Timeframe: 4 weeks

Activities Scale for Kids (ASKp) measured by a physiotherapist at 4 week visit and is a validated 38-questionnaire that targets activities of children. The minimal scores are 0 and maximum are 100. Higher score indicates higher function.

Outcome measures

Outcome measures
Measure	Immobilizaton Device n=50 Participants Below Knee walking cast	Immobilization Device n=54 Participants Removable ankle brace that you placed on the injured ankle and can be removed as needed by the patient
Functional Outcome as Measured by the Activities Scale for Kids at 4 Weeks From the Time of the Initial Injury	85.3 percentage of questions Standard Error 2.06	91.3 percentage of questions Standard Error 1.14

SECONDARY outcome

Timeframe: 4 weeks

Bieri Face Pain Scale (BFPS). This is scored as 0, 2, 4, 6, 8, 10. The minimum and maximum values are 0 and 10 respectively. A higher score reports worse pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Goniometer measured by a physiotherapist

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

parent reported costs and health care system costs

Outcome measures

Outcome data not reported

Adverse Events

Immobilizaton Device

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Immobilization Device

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Immobilizaton Device n=54 participants at risk Below Knee walking cast	Immobilization Device n=57 participants at risk Removable ankle brace
Skin and subcutaneous tissue disorders Poor Fit of Immobilization Device	7.4% 4/54 • Number of events 4 • 2 years	28.1% 16/57 • Number of events 16 • 2 years

Additional Information

Kathy Boutis

Hospital for Sick Children

Phone: 4168138982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place