Pediatric Femur Fracture Registry

NCT03211546 | Completed

• 1 other identifier: PedFemFx
• Study Type: observational
• Target: 322
• Locations: 5 countries
• Sites: 14

Brief 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

Keywords

Pediatric femur fracture; Spica casting; Traction; Intramedullary nailing; Children; Internal fixation; External fixation

Outcome Measures

Primary Outcomes (1)

• Fracture alignment

  Mechanical and anatomical axes

  up to 24 months

Secondary Outcomes (7)

• Range of Motion (ROM)

  up to 24 months

• Axial deviation

  up to 24 months

• Leg Length Discrepancy

  up to 24 months

• Quadriceps strength

  up to 24 months

• Return to full activity

  up to 24 months

Study Arms (1)

Femoral shaft fracture

Patients (children up to 16 years old) diagnosis of isolated closed femur shaft fracture (3.2-D) and open distal physis. Treatment strategies will follow standard of care (routine) procedures, either conservative (non-surgical) treatment or surgical treatment.

Procedure: Conservative (non-surgical) treatment; Procedure: Surgical treatment

Interventions

Conservative (non-surgical) treatment PROCEDURE

Spica cast Traction Traction and spica cast

Femoral shaft fracture

Surgical treatment PROCEDURE

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

Femoral shaft fracture

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Consecutive patients (children up to 16 years old) presenting with an isolated closed femur shaft fracture (3.2-D) and open distal physis.

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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (14)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Medical University Hospital of Graz

Graz, 8036, Austria

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

IWK Health Centre

Halifax, New Scotland, B3K-6R8, Canada

Location

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5P3E1, Canada

Location

Universitätsklinik Dresden

Dresden, 1307, Germany

Location

University Medicine Göttingen (UMG)

Göttingen, 37075, Germany

Location

Altonaer Kinderkrankenhaus GmbH

Hamburg, 22763, Germany

Location

Städt. Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

University of Leipzig

Leipzig, 4103, Germany

Location

University Hospital Tübingen

Tübingen, 72070, Germany

Location

Inselspital

Bern, 3010, Switzerland

Location

Childrens Hospital Zurich

Zurich, 8032, Switzerland

Location

MeSH Terms

Interventions

Therapeutics; Surgical Procedures, Operative

Study Officials

• Peter P. Schmittenbecher, Prof.

  Kinderchirurgische Klinik, Klinikum Karlsruhe

  PRINCIPAL INVESTIGATOR

• Unni G. Narayanan, Prof.

  The Hospital for Sick Children, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 7, 2017
• Study Start: March 14, 2018
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CA (4); CH (2); US (1); DE (6)