Advice

Summary

Summary

The PediGuard is a battery‑powered, single‑use tool for drilling pilot holes in spinal pedicles into which pedicle screws can be inserted during spinal surgery. Small comparative trials in different populations of adults and children show that the PediGuard can reduce exposure to fluoroscopy, has high sensitivity and specificity for detecting pedicle perforations, and can significantly reduce the number of malpositioned screws. The PediGuard costs £500 per unit compared with the standard pedicle awl, which costs about £300.

Product summary and likely place in therapy

  • The PediGuard is a single‑use device that is designed to drill through the vertebral pedicle to create a pilot hole for placing pedicle screws.

  • The PediGuard would be used in place of a standard pedicle awl in secondary and tertiary care during spinal surgery in which pedicle screws are placed. This would include spinal decompression or correction surgery where fusion and instrumentation are needed.

Effectiveness and safety

  • Evidence for the PediGuard comes from 4 controlled studies of variable design and quality, involving a total of 405 patients. None of the studies was done in the UK.

  • Two randomised controlled trials (n=42 people with 694 pedicle screws and n=18 with 78 pedicle screws) comparing the PediGuard with the standard method for drilling pilot holes demonstrated a statistically significant reduction in the number of fluoroscopy exposures needed when using the PediGuard.

  • Accuracy of pedicle screw placement was significantly improved in the first study (p=0.001) and non‑inferior in thesecond study (p>0.05).

  • A multicentre, non‑randomised controlled trial (n=97,571 pedicle screws inserted) showed that the PediGuard detected 22 of 23 pedicle perforations compared with 10 of 23 using other methods of detection. Overall, the PediGuard had a 94% positive predictive value and 100% negative predictive value, yielding 99% specificity and 98% sensitivity.

  • A retrospective controlled study (n=248) compared the PediGuard with a standard method for drilling pilot holes to insert pedicle screws in children and young people with scoliosis. There was a statistically significant reduction in the number of clinically relevant malpositioned screws when the PediGuard was used.

Technical factors

  • The PediGuard responds to the electrical conductivity of the tissue into which it is drilling in real time.

  • The PediGuard gives an alarm (through audio and visual feedback to the user) if the hole is being drilled into the wrong area of the pedicle, preventing potential spinal damage from malpositioned pedicle screws.

Cost and resource use

  • The PediGuard has an NHS acquisition cost of £500 per unit excluding VAT (compared with standard pedicle awls, which cost around £300, or cannulated pedicle awls, which cost around £750 excluding VAT).

  • No evidence on cost and resource use was available.