Pediatric Femur Fracture Registry (PedFemFx)

• Fracture alignment [ Time Frame: up to 24 months ]
  Mechanical and anatomical axes
  
  

• Range of Motion (ROM) [ Time Frame: up to 24 months ]
  ROM of the hip (flexion/extension, internal/external rotation and abduction/adduction) and the knee (flexion/extension)
  
  
• Axial deviation [ Time Frame: 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 [ Time Frame: up to 24 months ]
  The Leg Length Discrepancy (LLD) will be measured using the standing blocks method
  
  
• Quadriceps strength [ Time Frame: up to 24 months ]
  The quadriceps strength will be measure using the manual muscle testing.
  
  
• Return to full activity [ Time Frame: up to 24 months ]
  ime to full weight-bearing, time to full activity, and time to return to kindergarten/school.
  
  
• Patient-reported outcome [ Time Frame: up to 24 months ]
  Patient Reported Outcomes of Fracture Healing- Lower Limb
  
  
• Health Related Quality of Life [ Time Frame: up to 24 months ]
  EQ-5D-Y version proxy 1
  
  

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.