Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
1 other identifier
interventional
21
1 country
1
Brief Summary
Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing \& bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 19, 2013
CompletedFirst Posted
Study publicly available on registry
August 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 7, 2015
April 1, 2015
8 months
August 19, 2013
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days to Ambulation
Recorded in parent journal, date of first ambulation without assistance.
12 weeks
Secondary Outcomes (1)
Fracture displacement
12 weeks
Study Arms (3)
Short Leg Cast
ACTIVE COMPARATORPatient will be placed in a short leg cast for approximately 3 weeks or until radiographic union
No immobilization
EXPERIMENTALNo cast or splint will be applied to the injured extremity
Observational
OTHERPatient will be treated based on the parents comfort. This arm will consist of individuals in which the parent/guardian did not agree to randomization, but did consent for observational follow-up regardless of treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or oblique fracture of the tibial shaft or metaphysis.
You may not qualify if:
- Children with clinical suspicion but lack of radiographic evidence for toddler's fracture
- Fractures displaced \>2mm
- Open fractures
- Pathologic fracture
- Fractures involving the physis
- Previous fracture of the ipsilateral extremity
- Concomitant fracture involving the ipsilateral or contralateral leg
- Concomitant head injury
- Non-ambulatory children (i.e., those who have not yet begun to walk)
- Children with bone-metabolism disorders (i.e., osteogenesis imperfect, rickets)
- Children who are geographically prohibited from following up in our system
- Children whose caregivers are not proficient in English
- Presentation \>7 days from injury
- Cases considered to be non-accidental trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Greenville Hospital System
Greenville, South Carolina, 29605, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael L Beckish, MD
Greenville Hospital System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2013
First Posted
August 21, 2013
Study Start
June 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2015
Last Updated
April 7, 2015
Record last verified: 2015-04