Clinical trial NCT03211546: Pediatric Femur Fracture Registry
Official title: A Prospective Multicenter Observational Registry for Femoral Shaft Fractures in Children up to 16 Years of Age
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Femoral Shaft Fracture
Keywords: Pediatric femur fracture
Spica casting
Traction
Intramedullary nailing
Children
Internal fixation
External fixation
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 322
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: There is limited evidence about the comparative effectiveness of different treatments for pediatric femur fractures. The most common method used for isolated femur shaft fractures of children older than 5 years of age is elastic stable intramedullary nailing (ESIN). It is thought to be the ideal indication for children up to the age of 10 to 12 and it is the most commonly employed method of internal fixation in this age group, but other treatments include external fixation, plating, other forms of flexible or rigid intramedullary nailing and non-operative options such as spica casts or traction. In children under the age of 5 non-operative methods are believed to work well with few complications. Imperfect alignment is more acceptable because of the tremendous remodelling potential in young growing children. Internal fixation is believed to be unnecessary as it is more invasive, with some risk of complications and likely need for a second surgical procedure to remove it. Biomechanical properties are different in this age group. Consequently, operative treatment of these fractures is generally not recommended in children under the age of 3 according to the German guidelines (www.awmf.org), not under the age of 5 in the American guidelines (www.aaos.org); and in Great Britain, surgical management in preschool children is restricted to polytrauma and complex injuries (www.nice.org.uk).

Despite these recommendations and the general acceptance of non-operative treatment for younger children , a survey of clinical practice in Germany revealed that 50% of children under the age of 3 years are treated with ESIN, because some surgeons believe that patients seem less comfortable when treated with traction or spica casting and might experience a higher rate of loss of reduction. Consequently, the use of ESIN for fractures in preschool children has become more prevalent in the last years.

Similarly, there is wide variation in the preferred management of femoral shaft fractures in older children, with little evidence about the comparative effectiveness of different treatments for pediatric femur fractures. There is an imperative to collect prospective data to generate higher quality evidence.

The purpose of this proposed registry is to collect the clinical outcomes (fracture healing \& patient reported outcomes and complications) of the treatment of isolated femur shaft fractures in children up to skeletal maturity. Additionally, health economic aspects will be evaluated to give possible recommendations from a health economic perspective.

Eligibility 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

Primary outcomes:
measure: Fracture alignment
timeFrame: up to 24 months
Secondary outcomes:
measure: Range of Motion (ROM)
timeFrame: up to 24 months
measure: Axial deviation
timeFrame: up to 24 months
measure: Leg Length Discrepancy
timeFrame: up to 24 months
measure: Quadriceps strength
timeFrame: up to 24 months
measure: Return to full activity
timeFrame: up to 24 months
measure: Patient-reported outcome
timeFrame: up to 24 months
measure: Health Related Quality of Life
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Graz
country: Austria
facility: Medical University Hospital of Graz
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: New Scotland
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario (CHEO)
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Dresden
country: Germany
facility: Universitätsklinik Dresden
city: Göttingen
country: Germany
facility: University Medicine Göttingen (UMG)
city: Hamburg
country: Germany
facility: Altonaer Kinderkrankenhaus GmbH
city: Karlsruhe
country: Germany
facility: Städt. Klinikum Karlsruhe
city: Leipzig
country: Germany
facility: University of Leipzig
city: Tübingen
country: Germany
facility: University Hospital Tübingen
city: Bern
country: Switzerland
facility: Inselspital
city: Zürich
country: Switzerland
facility: Childrens Hospital Zurich
Study officials:
affiliation: Kinderchirurgische Klinik, Klinikum Karlsruhe
name: Peter P. Schmittenbecher, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children, Toronto
name: Unni G. Narayanan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: