Local Man Goes From Wheelchair To Walking 
Hours After Revolutionary Back Surgery at GBMC  

X STOP Spinal Implant Recently Approved by FDA

BALTIMORE/BOWIE, Md. – January 31, 2006 – A Bowie, Md. man nearly 100 percent confined to a bed or wheelchair since last fall due to a debilitating back injury took a pain-free walk 48 hours after undergoing revolutionary X-Stop back surgery recently at Greater Baltimore Medical Center.

Wayne Rardon, 63, says his goal is to “walk the Appalachian Trail and enjoy golf again.” In October 2005, Rardon severely injured his back trying to lift a concrete slab, resulting in two discs that were nearly touching and placing continual stress on the nerves in his legs, causing him great pain.  He also suffers from Parkinson’s disease and has been on medical leave after a 20-year career as a civilian electrical engineer for the United States Coast Guard.

On January 24^th, Rardon underwent X-Stop surgery with Charles Hartjen, M.D., co-medical director of GBMC’s Joint & Spine Center, and by 11 a.m. the following morning “my hospital gown was off, my trousers were on and I was up on my feet.”

X-Stop, a minimally invasive surgical alternative for patients suffering from lumbar spinal stenosis, recently received approval from the U.S. Food and Drug Administration for use in the United States after thousands of surgeries in Europe.  Lumbar spinal stenosis is the most common reason for back surgery in people over age 50 in the United States.  Dr. Hartjen was a lead investigator on the X-Stop clinical trial in the United States and is the only surgeon within several hundred miles performing the procedure. 

“X-Stop may soon be the standard of care for patients suffering from lumbar spinal stenosis who face debilitating back and leg pain on a daily basis,” said Dr. Hartjen, a resident of northern Baltimore County and a GBMC-affiliated physician for nearly two decades.  “Patients have experienced that this is truly a life-improving surgery.”

Rardon was looking for a procedure “that was less invasive, had less blood loss and a quicker recovery” than traditional back surgery, and opted for X-Stop.  The new procedure was also beneficial because Parkinson’s patients typically have a difficult time recovering from general anesthesia.

“Before injuring my back I was healthy and happy, walking, exercising and climbing stairs,” said Rardon.  “I’m already walking up to a half-mile and I have really great expectations for the future.”

X-Stop is completely reversible and an inpatient procedure that generally takes less than one hour.  The device is a spinal implant inserted using a minimally invasive procedure requiring only local anesthesia.  Since X STOP is not fixed to any bony structures, it does not result in fusion, thereby allowing patients more mobility and a quicker healing time.  

X-Stop is designed for patients suffering from lumbar spinal stenosis (LSS), a common spinal condition where space in the spinal canal shrinks, causing nerves to be squeezed and resulting in significant back and leg pain.  Following surgery, patients may experience rapid relief from their symptoms and are usually able to walk out of the hospital within 24 hours due to quick recovery and minimal risk of complications.

One of the patent holders for X-Stop, known formally as X STOP Interspinous Process Decompression, Dr. Hartjen performed more than 30 surgeries during the clinical trial at GBMC, which had the largest patient enrollment of nine hospitals in the country and was the only Maryland location.

In December 2005, Dr. Hartjen performed Maryland’s first FDA-approved X-Stop surgery - on a 76-year-old patient from Baltimore County, and he has consulted with patients from as far away as Ohio and Florida.

Other X-Stop patient testimonials:

Merrie Francis Miller, 75, of Ellicott City, Md., is enjoying a “new life” following X-Stop surgery in March 2001 as a clinical trial patient.

Several months before surgery, Miller was experiencing excruciating pain in her lower back and right leg, and had periods of numbness in the two smallest toes of her right foot for several years prior.  “My previous activities of tennis, three-mile walks, tending and taking care of three gardens, taking care of a family of three and a dozen grandchildren, and general daily normal active living was all severely limited,” Miller said during testimony before an FDA panel.  Six weeks after surgery, Miller took a granddaughter for a lengthy tour of France, and four years after surgery is free of pain and has full normal movement in any position needing a twist, a bend, or a turn of her back. 

Hilda Sparks of Upperco, Md. is another X-Stop success story from GBMC. At 68-years-old, Sparks had the surgery during the clinical trial after “four excruciatingly painful attacks caused by two herniated discs.”

“The day after surgery I felt immediate relief and was able to walk without pain,” Sparks said.  Within four weeks I was back on my riding lawn mower again.”

With more than 4,000 successful surgical implants so far, X-Stop is rapidly becoming a surgical treatment option of choice for mild to moderate spinal stenosis for patients in Europe and Japan. GBMC’s Dr. Hartjen has trained the head of the Swedish Spine Study Group in this surgical technique, and has received requests from physicians across the United States to learn the technique.

About GBMC
GBMC includes Greater Baltimore Medical Center (GBMC), Central Maryland’s leading community hospital; Hospice of Baltimore, which provides comfort and care to patients with life-limiting illnesses; the Harry and Jeanette Weinberg Community Health Center, which offers comprehensive health and family services to the residents of East Baltimore; and the GBMC Foundation, which supports the GBMC mission by managing fundraising efforts.  The 300-bed Medical Center, located on a beautiful suburban campus, serves nearly 22,000 inpatients annually and provides approximately 50,000 emergency room visits. For more information, go to www.gbmc.org.

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