Pediatric Femur Fracture Registry

Completed

Conditions studied: Femoral Shaft Fracture

In brief

Prospective data collection and evaluation of complete data sets will be performed in the course of routine clinical care of a cohort of consecutive patients (children up to 16 years old) presenting with an isolated femur shaft fracture. Data will be collected during follow-up visits at 3 to 6 weeks, 3, 6, 12 and 24 months, with additional follow-up visits as needed or dictated by individual practice. Final follow-up will be at 24 months, unless a patient requires additional follow-up or another intervention to address an unfavorable outcome (e.g. malalignment, nonunion, limb length discrepancy) noted at the 24 month follow-up visit.

Key facts

Study ID

NCT03211546

Run by

AO Innovation Translation Center

People needed

322

Starts

2018-03-14

Expected to finish

2024-06-10

Last updated by the study team

2025-08-29

Who can join

Age: any, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age less than 16 years of age at the time of the injury
• Open distal physis of the femur
• Diagnosis of isolated closed femur shaft fracture (3.2-D)
• Willingness and ability of the patient/parents/legally responsible care giver to participate in the clinical investigation including imaging and FU procedures as standard of care in each clinic
• Willingness and ability of the parent(s) to support the patient in his/her study participation
• Ability of parents to understand the content of the patient information / ICF and participation in the clinical investigation
• Signed ICF by patient and/or parent(s) according to local policies and regulations

You may not qualify if…

• Polytraumatized patient
• Closed distal physis of the femur
• Pathologic fractures and fractures in patients with metabolic bone disease, osteogenesis imperfecta, neuromuscular disorder, endocrinologic disease or other conditions influencing the bony structure
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States
• Medical University Hospital of Graz — Graz, Austria
• BC Children's Hospital — Vancouver, British Columbia, Canada
• IWK Health Centre — Halifax, New Scotland, Canada
• Children's Hospital of Eastern Ontario (CHEO) — Ottawa, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Universitätsklinik Dresden — Dresden, Germany
• University Medicine Göttingen (UMG) — Göttingen, Germany
• Altonaer Kinderkrankenhaus GmbH — Hamburg, Germany
• Städt. Klinikum Karlsruhe — Karlsruhe, Germany
• University of Leipzig — Leipzig, Germany
• University Hospital Tübingen — Tübingen, Germany
• Inselspital — Bern, Switzerland
• Childrens Hospital Zurich — Zurich, Switzerland

Full record on ClinicalTrials.gov

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