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OpenTrials
Completed

NCT Number: NCT01926795

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

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.

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Key information

Conditions

Tibial Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short leg cast

Procedure

No Immobilization

Procedure

Primary outcomes

  1. Days to Ambulation

    Time frame: 12 weeks

    Recorded in parent journal, date of first ambulation without assistance.

Secondary outcomes

  1. Fracture displacement

    Time frame: 12 weeks

    Displacement of the fracture greater than 2 mm in any direction.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 21, 2013
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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