Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT01926795
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
5 Years
Study:
NCT01926795
Study Brief:
Protocol Section:
NCT01926795