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Femoral Shaft FracturePedFemFxNCT03211546

Pediatric Femur Fracture Registry

An observational study of Femoral Shaft Fracture, run by AO Innovation Translation Center at 14 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Femoral Shaft Fracture
What is being tested?
Conservative (non-surgical) treatment and Surgical treatment
Type of treatment
Surgery or procedure
How many people
322 participants
Where
14 sitesin 5 countries
Study dates
14 Mar 2018to 10 Jun 2024
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 5 countries.

14 sites in 5 countries

Germany6 sites
  • Universitätsklinik Dresden

    Dresden, 1307

  • University Medicine Göttingen (UMG)

    Göttingen, 37075

  • Altonaer Kinderkrankenhaus GmbH

    Hamburg, 22763

  • Städt. Klinikum Karlsruhe

    Karlsruhe, 76133

  • University of Leipzig

    Leipzig, 4103

  • University Hospital Tübingen

    Tübingen, 72070

Other trials in Germany

Canada4 sites
  • IWK Health Centre

    Halifax, New Scotland, B3K-6R8

  • Children's Hospital of Eastern Ontario (CHEO)

    Ottawa, Ontario, K1H 8L1

  • The Hospital for Sick Children

    Toronto, Ontario, M5P3E1

  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

Switzerland2 sites
  • Inselspital

    Bern, 3010

  • Childrens Hospital Zurich

    Zurich, 8032

Other trials in Switzerland

United States1 site
  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

Austria1 site
  • Medical University Hospital of Graz

    Graz, 8036

Other trials in Austria

About this study

Official title: A Prospective Multicenter Observational Registry for Femoral Shaft Fractures in Children up to 16 Years of Age

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.

Read the 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.

Being tested
Conservative (non-surgical) treatment, Surgical treatment
Keywords
Pediatric femur fracture, Spica casting, Traction, Intramedullary nailing, Children, Internal fixation, External fixation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conservative (non-surgical) treatmentProcedure or surgery

    Spica cast Traction Traction and spica cast

  • Surgical treatmentProcedure or surgery

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

Study groups in NCT03211546
Study groupRoleWhat they receive
Femoral shaft fracturePatients (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.
Receives: Procedure: Conservative (non-surgical) treatment; Procedure: Surgical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fracture alignment

    Mechanical and anatomical axes

    Measured: up to 24 months

Secondary outcomes (7)
  1. Range of Motion (ROM)

    ROM of the hip (flexion/extension, internal/external rotation and abduction/adduction) and the knee (flexion/extension)

    Measured: up to 24 months

  2. Axial deviation

    Varus/valgus malalignment, flexion/extension deficit or rotational malalignment will be evaluated compared to the contralateral (healthy) leg

    Measured: up to 24 months

  3. Leg Length Discrepancy

    The Leg Length Discrepancy (LLD) will be measured using the standing blocks method

    Measured: up to 24 months

  4. Quadriceps strength

    The quadriceps strength will be measure using the manual muscle testing.

    Measured: up to 24 months

  5. Return to full activity

    ime to full weight-bearing, time to full activity, and time to return to kindergarten/school.

    Measured: up to 24 months

  6. Patient-reported outcome

    Patient Reported Outcomes of Fracture Healing- Lower Limb

    Measured: up to 24 months

  7. Health Related Quality of Life

    EQ-5D-Y version proxy 1

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2017
  2. Study start14 Mar 2018
  3. Primary completion10 Jun 2024
  4. Study completion10 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
322 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03211546
Sponsor's protocol ID
PedFemFx
Acronym
PedFemFx
Status last verified
Aug 2025
First submitted
6 Jul 2017
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Femoral Shaft Fracture, run by AO Innovation Translation Center at 14 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Canada, Switzerland, United States, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fracture alignment (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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