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
About this trial
This is an interventional treatment trial for Tibial Fractures focused on measuring toddler's fracture, tibial fracture, children
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
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
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
We'll reach out to this number within 24 hrs