Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
Completed · Not applicable
Conditions studied: Tibial Fractures
In brief
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.
Key facts
- Study ID
- NCT01926795
- Run by
- Prisma Health-Upstate
- People needed
- 21
- Starts
- 2013-06-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2015-04-07
Who can join
Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Greenville Hospital System — Greenville, South Carolina, United States
Full record on ClinicalTrials.gov
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