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

April 6, 2015 updated by: Prisma Health-Upstate
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Short Leg Cast
Patient will be placed in a short leg cast for approximately 3 weeks or until radiographic union
Procedure: Short leg cast
Experimental: No immobilization
No cast or splint will be applied to the injured extremity
Procedure: No Immobilization
Other: Observational
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.
Procedure: Short leg cast
Procedure: No Immobilization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Investigators

  • Principal Investigator: Michael L Beckish, MD, Greenville Hospital System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00025178

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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