Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
NCT ID: NCT01926795
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2013-06-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short Leg Cast
Patient will be placed in a short leg cast for approximately 3 weeks or until radiographic union
Short leg cast
No immobilization
No cast or splint will be applied to the injured extremity
No Immobilization
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.
Short leg cast
No Immobilization
Interventions
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Short leg cast
No Immobilization
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Year
5 Years
ALL
No
Sponsors
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Prisma Health-Upstate
OTHER
Responsible Party
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Principal Investigators
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Michael L Beckish, MD
Role: PRINCIPAL_INVESTIGATOR
Greenville Hospital System
Locations
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Greenville Hospital System
Greenville, South Carolina, United States
Countries
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Other Identifiers
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Pro00025178
Identifier Type: -
Identifier Source: org_study_id
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