MedTrace Logo

Pediatric Femur Fracture Registry

NCT03211546 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 322

Last updated 2025-08-29

No results posted yet for this study

Summary

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.

Conditions

  • Femoral Shaft Fracture

Interventions

PROCEDURE

Conservative (non-surgical) treatment

Spica cast Traction Traction and spica cast

PROCEDURE

Surgical treatment

Elastic Stable Intramedullary Nailing (ESIN) Conventional locking intramedullary nail Plating External fixation

Sponsors & Collaborators

  • AO Innovation Translation Center

    lead OTHER

Principal Investigators

  • Peter P. Schmittenbecher, Prof. · Kinderchirurgische Klinik, Klinikum Karlsruhe

  • Unni G. Narayanan, Prof. · The Hospital for Sick Children, Toronto

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2024-06-10
Completion
2024-06-10

Countries

  • United States
  • Austria
  • Canada
  • Germany
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03211546 on ClinicalTrials.gov