Pediatric Femur Fracture Registry

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.

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