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

Primary Purpose

Tibial Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short leg cast
No Immobilization
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring toddler's fracture, tibial fracture, children

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Greenville Hospital System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Short Leg Cast

No immobilization

Observational

Arm Description

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

No cast or splint will be applied to the injured extremity

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2013
Last Updated
April 6, 2015
Sponsor
Prisma Health-Upstate
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1. Study Identification

Unique Protocol Identification Number
NCT01926795
Brief Title
Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
Official Title
Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
toddler's fracture, tibial fracture, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Leg Cast
Arm Type
Active Comparator
Arm Description
Patient will be placed in a short leg cast for approximately 3 weeks or until radiographic union
Arm Title
No immobilization
Arm Type
Experimental
Arm Description
No cast or splint will be applied to the injured extremity
Arm Title
Observational
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Short leg cast
Intervention Type
Procedure
Intervention Name(s)
No Immobilization
Primary Outcome Measure Information:
Title
Days to Ambulation
Description
Recorded in parent journal, date of first ambulation without assistance.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fracture displacement
Description
Displacement of the fracture greater than 2 mm in any direction.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Beckish, MD
Organizational Affiliation
Greenville Hospital System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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