Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 1 - 5 |
| Updated: | 2/7/2015 |
| Start Date: | June 2013 |
| Contact: | Stephanie L Tanner, MS |
| Email: | stanner@ghs.org |
| Phone: | 864-455-1303 |
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.
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.
Inclusion Criteria:
- • Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or
oblique fracture of the tibial shaft or metaphysis.
Exclusion Criteria:
- • 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
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