Flexible nail has better outcomes for pediatric fractures
By Sally Chapralis
Children with femoral shaft fractures who have been treated with a new flexible interlocking intramedullary nail (FIIN) demonstrate better outcomes than those treated with standard surgical techniques (SST), according to the results presented in poster exhibit P472. They have fewer complications, heal sooner and can bear weight sooner as well.
Researchers reviewed hospital and outpatient medical records for pediatric patients (ages 7 to 19 years old) who had been treated with either FIIN or SST for femoral shaft fractures requiring open treatment. The FIIN, also known as the pediatric locking nail manufactured by Biomet, is FDA-approved for the treatment of pediatric femoral fractures.
The 137 children selected by researchers—59 in the FIIN group and 78 in the SST group—shared similar age, gender and fracture characteristics. The average age was 11.5 years; 73.7 percent were male. The typical fracture pattern was transverse and comminuted, and was located in the second or third quarter of the femoral shaft.
Complications occurred in 20.3 percent of the FIIN patients and in 30.8 percent of the SST group. Trochanteric heterotopic ossification was the most common complication in the FIIN group, affecting 13.6 percent of the patients. In the SST group, superficial infection was the most common complication, affecting 12.8 percent of the SST patients.
Less than 2 percent of the FINN group experienced any major complications (e.g., avascular necrosis, malunion, deep infection and refracture). Among SST patients, however, 11.5 percent experienced major complications.
The FIIN group achieved full weight bearing 34 days sooner (p = 0.001) than the SST group. Radiographic healing also occurred earlier—37.4 days sooner (p = 0.043) in the FIIN group than in the SST group.
Researchers include Jonathan H. Phillips, MD; Lloyd N. Werk, MD, MPH, and Stacy A. Wiltrout, MA, MS, all of Orlando, Fla., and Lubica Jencikova-Celerin, MD, PhD, of London, Ontario, Canada. Support for this study was provided by the Nemours Children’s Clinic Orlando; Dr. Phillips receives royalties from Biomet.