Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03211546 |
| Other study ID # |
PedFemFx |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 14, 2018 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
February 2024 |
| Source |
AO Innovation Translation Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
