Our three-year-old granddaughter is going to have spinal fusion for a severe, severe scoliosis. She is developmentally disabled with a rare chromosomal abnormality. The surgeon showed us the screws they will use to hold the spine in place. She called them peddle screws and mentioned they are considered “off-label” but still safe. When I looked on-line about what off-label means, I got a little nervous about this for our girl. Are these things really safe?

According to a recent study done at The Musculoskeletal Research Center (Children’s Hospital in Colorado), pedicle screws for spinal stabilization are considered safe, reliable, and effective. Compared with other types of fixation (hooks, wires, rods), pedicle screws have a lower rate of complications. Superior correction of spinal deformity with fewer problems make pedicle screws (as a fixation device) the preferred choice of many surgeons.

The pedicle is a column of the vertebra between the main body and the back half of the spinal bones. Placement of a screw through this portion of the vertebra has some risks but many advantages over other types of fixation (e.g., wires, hooks). For example, there is less movement in screws compared with wires or hooks. This increased stability of the fixation device reduces the risk that the hardware will poke into the spinal canal damaging the spinal cord. Likewise, there is less risk of injury to blood vessels in the area.

Pedicle screws are also able to give better correction of the spinal deformity by providing multiplanar correction. Vertebral bones are able to rotate, flex, and extend as well as slide and glide slightly forward, back, and sideways. Multiplanar stabilization stops motion in all directions. Studies show that pedicle screws used in the lumbar and thoracic spines of adolescents and adults are less likely to pull out or fail compared with hooks and wires.

The use of pedicle screws in the 13 to 18 year old patient for spinal stabilization has been approved by the Food and Drug Administration (FDA). Its use in younger children has not yet been approved because of a lack of evidence for the safety of this device in this age younger group. But when pedicle screws are used for younger children, it is referred to as off-label (because of the lack of FDA approval at this time).

With this study (and other similar reports), it looks like complications from the off-label use among younger children are no different than with the adolescent group. This data may help spur other studies with the eventual outcome of FDA approval of pedicle screws for spinal stabilization in young children.