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.
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
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
Switzerland2 sites
Inselspital
Bern, 3010
Childrens Hospital Zurich
Zurich, 8032
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
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.
- Conditions
- Femoral Shaft Fracture
- 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 group | Role | What they receive |
|---|---|---|
| Femoral shaft fracture | Patients (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.
Fracture alignment
Mechanical and anatomical axes
Measured: up to 24 months
Secondary outcomes (7)
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
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
Leg Length Discrepancy
The Leg Length Discrepancy (LLD) will be measured using the standing blocks method
Measured: up to 24 months
Quadriceps strength
The quadriceps strength will be measure using the manual muscle testing.
Measured: up to 24 months
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
Patient-reported outcome
Patient Reported Outcomes of Fracture Healing- Lower Limb
Measured: up to 24 months
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.
- First posted7 Jul 2017
- Study start14 Mar 2018
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Shaft FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter P. Schmittenbecher, Prof., Principal investigator, Kinderchirurgische Klinik, Klinikum KarlsruheUnni G. Narayanan, Prof., Principal investigator, The Hospital for Sick Children, Toronto
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Observational Registry for Femoral Shaft Fractures in Children up to 16 Years of Age
- ClinicalTrials.gov ID
- NCT03211546
- Acronym / sponsor ID
- PedFemFx / PedFemFx
- Conditions
- Femoral Shaft Fracture
- Keywords
- Pediatric femur fracture, Spica casting, Traction, Intramedullary nailing, Children, Internal fixation, External fixation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral shaft fracture | – | Procedure: Conservative (non-surgical) treatment, Procedure: Surgical treatmentPatients (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. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative (non-surgical) treatmentSpica cast Traction Traction and spica cast | Procedure or surgery | Femoral shaft fracture |
| Surgical treatmentElastic Stable Intramedullary Nailing (ESIN) Conventional locking intramedullary nail Plating External fixation | Procedure or surgery | Femoral shaft fracture |
Primary outcome
Fracture alignment
Time frame: up to 24 months
Mechanical and anatomical axes
7 secondary outcomes
Range of Motion (ROM)
Time frame: up to 24 months
Axial deviation
Time frame: up to 24 months
Leg Length Discrepancy
Time frame: up to 24 months
Quadriceps strength
Time frame: up to 24 months
Return to full activity
Time frame: up to 24 months
Patient-reported outcome
Time frame: up to 24 months
Health Related Quality of Life
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Femoral Shaft Fracture
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Feasibility of Structured Resistance Training After Lower Extremity Fracture
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Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter P. Schmittenbecher, Prof. principal investigator
Kinderchirurgische Klinik, Klinikum Karlsruhe
Unni G. Narayanan, Prof. principal investigator
The Hospital for Sick Children, Toronto
14 sites in 5 countries: see every site and its status.
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.