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

NCT01926795 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-04-07

No results posted yet for this study

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.

Conditions

  • Tibial Fractures

Interventions

PROCEDURE

Short leg cast

PROCEDURE

No Immobilization

Sponsors & Collaborators

  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Michael L Beckish, MD · Greenville Hospital System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01926795 on ClinicalTrials.gov