Osteoporosis is a common disease in elderly populations and is a major public health problem worldwide that often leads to spinal degeneration and deformity. Therefore, it is very important to have a safe and accurate way to insert pedicle screws in these patients.

A clinical study was conducted to determine the relative effectiveness and assistance of the DSG Technology compared to a freehand technique assisted by lateral fluoroscopy in the preparation of the pilot holes for placement of pedicle screws in patients with osteopenia or osteoporosis.

Clinical Study part #1¹

In a randomized clinical study including 108 patients, 97 patients had osteoporosis and 11 patients had osteopenia:

• 97.3% of the screws accurately placed with the PediGuard probe instead of 90.8% without the PediGuard probe
• 54% less fluoroscopic shots with the PediGuard.

Even in patients with osteoporosis or osteopenia, the PediGuard probe demonstrates at least 3 times less pedicle breaches (>2mm).

Clinical Study part #2¹

Operative levels were from T3 to S1. Pedicle preparation was using either DSG or the free-hand technique. A total of 657 pedicle screws were placed.

• Reduction of radiation was decreased by 74% (P<0.0001) (Fig. 1).
• This combination of pedicle preservation and reduction of pedicle breaches during preparation led to a higher screw placement accuracy rate in the DSG assisted group. There was a 11% breach rate in the Standard Technique group and a 2.6% breach rate in the DSG assisted group (P<0.0001) (Fig. 2).

The use of Dynamic Surgical Guidance showed statistically significant differences in radiation exposure, screw placement accuracy and intra-operative pedicle preparation breaches.

These studies demonstrate that DSG has the potential for safely and effectively treating patients with demineralized bone.