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

Prisma Health-Upstate

Status: Completed

Conditions: Tibial Fractures

Treatments: Procedure: Short leg cast; Procedure: No Immobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT01926795

Pro00025178

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Short Leg Cast

Active Comparator group

Description:

Patient will be placed in a short leg cast for approximately 3 weeks or until radiographic union

Treatment:

Procedure: Short leg cast

No immobilization

Experimental group

Description:

No cast or splint will be applied to the injured extremity

Treatment:

Procedure: No Immobilization

Observational

Other group

Description:

Patient 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.

Treatment:

Procedure: No Immobilization

Procedure: Short leg cast