Pediatric Femur Fracture Registry
- Conditions
- Femoral Shaft Fracture
- Interventions
- Procedure: Conservative (non-surgical) treatmentProcedure: Surgical treatment
- Registration Number
- NCT03211546
- Lead Sponsor
- AO Innovation Translation Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 322
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Femoral shaft fracture Conservative (non-surgical) treatment 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. Femoral shaft fracture Surgical treatment 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.
- Primary Outcome Measures
Name Time Method Fracture alignment up to 24 months Mechanical and anatomical axes
- Secondary Outcome Measures
Name Time Method Range of Motion (ROM) up to 24 months ROM of the hip (flexion/extension, internal/external rotation and abduction/adduction) and the knee (flexion/extension)
Quadriceps strength up to 24 months The quadriceps strength will be measure using the manual muscle testing.
Patient-reported outcome up to 24 months Patient Reported Outcomes of Fracture Healing- Lower Limb
Axial deviation up to 24 months Varus/valgus malalignment, flexion/extension deficit or rotational malalignment will be evaluated compared to the contralateral (healthy) leg
Leg Length Discrepancy up to 24 months The Leg Length Discrepancy (LLD) will be measured using the standing blocks method
Health Related Quality of Life up to 24 months EQ-5D-Y version proxy 1
Return to full activity up to 24 months ime to full weight-bearing, time to full activity, and time to return to kindergarten/school.
Trial Locations
- Locations (14)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
IWK Health Centre
🇨🇦Halifax, New Scotland, Canada
Children's Hospital of Eastern Ontario (CHEO)
🇨🇦Ottawa, Ontario, Canada
Altonaer Kinderkrankenhaus GmbH
🇩🇪Hamburg, Germany
University Medicine Göttingen (UMG)
🇩🇪Göttingen, Germany
Universitätsklinik Dresden
🇩🇪Dresden, Germany
University of Leipzig
🇩🇪Leipzig, Germany
Städt. Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
University Hospital Tübingen
🇩🇪Tübingen, Germany
Childrens Hospital Zurich
🇨🇭Zürich, Switzerland
Inselspital
🇨🇭Bern, Switzerland
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Medical University Hospital of Graz
🇦🇹Graz, Austria