Patients Benefit From Knowing Surgery Risks

A symptom of an aching back will affect eight out of 10 people at some point in their lives. Almost all back pain will subside over time on its own with rest, physical therapy or pain management. But in rare cases of spinal trauma or tumor, of an actual deformity, or a chronic degenerative condition, the patient may be referred for a surgical intervention that involves the use of rods affixed to the vertebrae thanks to pedicle screws.

Surgeons are incredibly well-trained and expert at inserting pedicle screws. Yet the fact remains, when they put a screw into a vertebral pedicle, they are often working no more than a few millimeters from spinal cord or other delicate anatomical structures. There is very little room for error.

A significant advance in the continuous efforts to improve the success rate of pedicle screw placement has now been cleared by the U.S. Food and Drug Administration (FDA). Compared to standard techniques, PediGuard™, a device manufactured by SpineVision, offers interesting advantages.

Pedicle Screws are the Gold Standard

Pedicle screws, which act as reliable anchor points for a connecting / strengthening rod, have dramatically improved the outcomes of spinal fusion procedures by increasing stability. For the most part, pedicle screws have proven to be practical, safe and effective if carefully applied. To place pedicle screw the surgeon prepares a pilot hole with a mechanical awl in the narrow zone of the vertebral pedicle. Several techniques have been developed to insure correct positioning of the screws, all having their advantages and drawbacks, so that correct pedicle screw placement remains in some cases a true challenge. As with any form of surgery, there are risks and complications.

A well-known complication associated with the standard approach of pedicle screw insertion is the occurrence of a cortical breach, i.e. an accidental perforation of the vertebral pedicle wall. Published studies have reported the cortical breach in pedicle screw procedures rate at around 10 percent all the way to 40 percent depending on detection criteria and follow-up examination.

Screw is too lateral and may damage soft tissue or nerves

Right-hand screw is too medial and may damage spinal cord

Screws are correctly placed within the pedicles

Patients are routinely informed of this failure rate/risk when they are asked to sign the pre-op written consent form. Patients should not panic at the numbers of breaches as most do not cause complications. Even if a pedicle screw perforates the cortical wall, for the most part, there will not be serious pathological consequences. Still, the better the screws are positioned, the stronger the construct will be, for an optimal surgical outcome.

Now, a very simple device exists to help the surgeon correctly place pedicle screws: PediGuard™ is the only pilot hole drilling device to alert the surgeon in real-time to a possible vertebral cortex perforation, by emission of audio and visual alarm signals. If required, the surgeon may immediately redirect his pilot hole. A further advantage of the use of the device is that it significantly decreases the need for X Rays that are commonly used to monitor pedicle screw placement in spinal procedures.

As increasing numbers of U.S. surgeons are being trained to use the PediGuard™ in their pedicle screw procedures, the device is becoming standard operating procedure as a unique response to pedicle screw placement and radiation exposure issues.