A Prospective Multicenter Observational Registry for Femoral Shaft Fractures in Children up to 16 Years of Age
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Femoral Shaft Fracture
- Sponsor
- AO Innovation Translation Center
- Enrollment
- 322
- Locations
- 14
- Primary Endpoint
- Fracture alignment
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Fracture alignment
Time Frame: up to 24 months
Mechanical and anatomical axes
Secondary Outcomes
- Range of Motion (ROM)(up to 24 months)
- Quadriceps strength(up to 24 months)
- Patient-reported outcome(up to 24 months)
- Axial deviation(up to 24 months)
- Leg Length Discrepancy(up to 24 months)
- Health Related Quality of Life(up to 24 months)
- Return to full activity(up to 24 months)