For decades, moderate to major surgery was the only effective treatment for spinal stenosis, a degenerative condition that shrinks the spinal canal and pinches the nerves, causing lower back pain and shooting pains down the legs. 

In 1995, however, orthopedic surgeon James Zucherman, MD, began seeking an alternative to surgery when one of his stenosis patients had a bad response to general anesthesia. 

Working with Ken Hsu, MD, Zucherman developed the X-Stop device, a titanium implant that opens up the space in the spinal canal.  After years of research and clinical trials, the X-Stop received approval for general use from the U.S. Food and Drug Administration last October.

“Spinal stenosis is the most common back problem for people over age 50,” Zucherman explains.  “People who have spinal stenosis generally experience pain while standing or walking, but they are comfortable when they sit.  So we created a device that would maintain the same space in the spinal column that is there when the patient is sitting.   We ran a pilot program with 10 patients in 1997 and then progressed to clinical trials.  Of the patients from the initial group in 1997, only two had to have subsequent back surgery – including one who had a problem in an area not targeted by the X-Stop implant.”

Now practicing at St. Luke’s Hospital with fellow spine surgeon Fred Naraghi, MD, Zucherman notes that the X-Stop implant has a high success rate.  “The studies show that the success rate for the X-Stop is as good as or better than standard surgery, with much fewer risks,” he says.  “Approximately 200,000 patients undergo major surgery such as laminectomy or laminectomy with fusion for spinal stenosis every year, with a four- to six-day hospital stay.  The rate of major and minor complications is 10 percent for laminectomy, and 15 percent for laminectomy with fusion. The X-Stop procedure is performed in under half an hour with only local anesthesia and the patient generally can go home after one day.  The risk of minor complications is 4 percent -- approximately the same as for a spinal epidural injection.”

The X-Stop device is placed between the spinous processes – the bony projections at the back of the vertebrae – just underneath the skin.  The implant effectively provides “decompression,” increasing the area of the spinal column and relieving the patient’s symptoms.

Naraghi, who has performed more than 60 X-Stop procedures so far, says the recovery period for X-Stop patients is dramatically shorter than that for surgery patients.  “With major spine surgery, recovery can take up to 12 months,” he comments.  “Patients who receive an X-Stop implant can go back to their regular activities within a few days, except for heavy lifting or strenuous exercise.  After about two months, they can generally resume all activities.  We’ve seen no indications of the body rejecting the X-Stop device, and the implant has been shown to have long-lasting results.”

Zucherman and Naraghi regularly make presentations explaining the X-Stop procedure to other physicians, and doctors from around the country have come to San Francisco to train with them.  St. Luke’s Hospital is one of only two hospitals in the city where the procedure is currently performed.

For more information about the X-Stop procedure or to schedule a consultation, please call Naraghi in the Orthopedics Department at St. Luke’s, (415) 642-0707, or Zucherman’s office at (415) 750-5835.