The safety of spinal pedicle screws in children ages 1 to 12.

BACKGROUND CONTEXT: Pedicle screws have shown to be a safe and effective method of spinal fixation, offering superior multiplanar correction compared with hooks or sublaminar wires in selected situations. Though only food and drug administration (FDA) approved in the adolescent population, they are commonly used in an off-label manner in the preadolescent population.

PURPOSE: To determine if the complication rate of the off-label use of pedicle screws for spinal fixation in the preadolescent 0- to 12-year-old population is comparable with the complication rate in the FDA-approved 13- to 18-year-old population.

STUDY DESIGN/SETTING: Retrospective medical record and radiograph review.

PATIENT SAMPLE: A total of 726 pediatric patients who underwent a spinal fusion procedure at a single tertiary institution between January 2003 and December 2008 were reviewed.

OUTCOME MEASURES: Incidence of instrumentation failure, infection, neurological complication, and total complications.

METHODS: The study population was divided into two groups based on age: the younger group included 0- to 12-year olds and the older group included 13- to 18-year olds at the time of surgery. Groups were further subdivided based on diagnosis: "A," neuromuscular scoliosis; "B," idiopathic scoliosis, and "C," other spinal deformities. Rates of neurovascular complications, infections, and instrumentation complications were compared statistically between the younger and the older groups. Only patients with greater than or equal to 1-year follow-up and greater than or equal to 2-year follow-up were included in the calculations for infection and instrumentation complication rates, respectively.

RESULTS: There were 206 patients (33% males, 67% females) in the younger group (0 to 12 years) and 520 (41% males, 59% females) in the older group (13 to 18 years). Overall, younger group had a 13.6% complication rate compared with 16.9% in the older group. Younger subjects showed a 13.4% complication rate because of instrumentation-related complications, 0.5% for neurovascular complications, and an infection rate of 9.2%. The older group showed a 15.4% complication rate because of instrumentation-related complications, 1.92% for neurovascular complications, and an infection rate of 11.0%. Complication rates were statistically insignificant between the two groups. Other complications in the younger group included one patient with aspiration pneumonia, two with ileus, and one with pulmonary and other complications in the older group included one patient with aspiration pneumonia, two with ileus, three with superior mesenteric artery syndrome, and three with wound dehiscence.

CONCLUSIONS: The complication rates in the young pediatric population associated with the off-label use of pedicle screws for spinal fusions are not statistically different from the complication rates associated with the FDA-approved adolescent population.