Pediatric Femur Fracture Registry

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT03211546
• Date of registration: 06/07/2017
• Prospective Registration: Yes
• Primary sponsor: AO Clinical Investigation and Publishing Documentation
• Public title: Pediatric Femur Fracture Registry PedFemFx
• Scientific title: A Prospective Multicenter Observational Registry for Femoral Shaft Fractures in Children up to 16 Years of Age
• Date of first enrolment: March 14, 2018
• Target sample size: 322
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03211546
• Study type: Observational [Patient Registry]

Countries of recruitment

Austria, Canada, Germany, Switzerland, United States

Contacts

• Name: Peter P. Schmittenbecher, Prof.
• Affiliation: Kinderchirurgische Klinik, Klinikum Karlsruhe

• Name: Unni G. Narayanan, Prof.
• Affiliation: The Hospital for Sick Children, Toronto

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: N/A
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Femoral Shaft Fracture

Intervention(s)

Procedure: Surgical treatment

Procedure: Conservative (non-surgical) treatment

Primary Outcome(s)

Fracture alignment [Time Frame: up to 24 months]

Secondary Outcome(s)

Patient-reported outcome [Time Frame: up to 24 months]

Range of Motion (ROM) [Time Frame: up to 24 months]

Return to full activity [Time Frame: up to 24 months]

Axial deviation [Time Frame: up to 24 months]

Leg Length Discrepancy [Time Frame: up to 24 months]

Health Related Quality of Life [Time Frame: up to 24 months]

Quadriceps strength [Time Frame: up to 24 months]

Secondary ID(s)

PedFemFx

Source(s) of Monetary Support

Please refer to primary and secondary sponsors