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

Not Applicable

Completed

• Conditions: Tibial Fractures
• Interventions: Procedure: No Immobilization; Procedure: Short leg cast

• Registration Number: NCT01926795
• Lead Sponsor: Prisma Health-Upstate

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-21
• Primary Completion: 2014-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No immobilization	No Immobilization	No cast or splint will be applied to the injured extremity
Short Leg Cast	Short leg cast	Patient will be placed in a short leg cast for approximately 3 weeks or until radiographic union
Observational	Short leg cast	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.
Observational	No Immobilization	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.

Primary Outcome Measures

Name	Time	Method
Days to Ambulation	12 weeks	Recorded in parent journal, date of first ambulation without assistance.

Secondary Outcome Measures

Name	Time	Method
Fracture displacement	12 weeks	Displacement of the fracture greater than 2 mm in any direction.

Trial Locations

Locations (1)

Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States