Trials / Completed
CompletedNCT01926795
Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Prisma Health-Upstate · Academic / Other
- Sex
- All
- Age
- 1 Year – 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Short leg cast | |
| PROCEDURE | No Immobilization |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2014-02-01
- Completion
- 2015-02-01
- First posted
- 2013-08-21
- Last updated
- 2015-04-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01926795. Inclusion in this directory is not an endorsement.