Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926795

Enrollment

Registered

2013-08-21

Start date

2013-06-30

Completion date

2015-02-28

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Fractures

Keywords

toddler's fracture, tibial fracture, children

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.

Interventions

PROCEDUREShort leg cast

PROCEDURENo Immobilization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 5 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Days to Ambulation	12 weeks	Recorded in parent journal, date of first ambulation without assistance.

Secondary

Measure	Time frame	Description
Fracture displacement	12 weeks	Displacement of the fracture greater than 2 mm in any direction.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026