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

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926795
• Other study ID #: Pro00025178
• Status: Completed
• Phase: N/A
• First received: August 19, 2013
• Last updated: April 6, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Greenville Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Procedure:
• Short leg cast

• No Immobilization

Locations

Country	Name	City	State
United States	Greenville Hospital System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Greenville Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days to Ambulation	Recorded in parent journal, date of first ambulation without assistance.	12 weeks	No
Secondary	Fracture displacement	Displacement of the fracture greater than 2 mm in any direction.	12 weeks	Yes