Glen Cove Orthopedic Surgeon Implants New High-Tech Spinal Device to Relieve Debilitating Low Back and Leg Pain
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Vincent Leone, MD, part of Global Design Team for Vetebral Replacement Technology Vincent Leone, MD, director of orthopedic spine surgery at Glen Cove Hospital, has performed one of the first surgeries in the United States using a new spinal implant to treat debilitating low back pain caused by degenerative disc disease and other spine disorders. The stand-alone implant, known as ROI-A™, is a partial vertebral (front of spine) replacement device used to stabilize the spine. It is made of high-density plastic and has an upper and lower metal clip, which deploys through the cage of the device and affixes to the vertebral body above and below, acting like a molly screw that secures both sides of a wall. Developed by LDR, a total spine solution company based in Austin, TX, the device was approved by the US Food and Drug Administration (FDA) on April 21. Dr. Leone was part of the global design team for the new implant and its instrumentation. He also is a member of North Shore-LIJ’s Institute for Orthopedic Science. Coinciding with the device’s FDA approval, Veronica Goldman, a long-time patient of Dr. Leone’s, had an appointment scheduled with him. Ms. Goldman, 54, had three lumbar (low back) discectomies over the past 10 years to alleviate her chronic, severe low back and leg pain, achieving only temporary relief. Her pain interfered with all aspects of daily living, such as walking, sleeping, driving, housekeeping and working (she was a former medical receptionist); she became disabled in 2005. Ms. Goldman was prepared to schedule a two-day, six-hour spinal fusion surgery to stabilize her spine from the front and the back, a procedure she and her husband had discussed with Dr. Leone on several occasions. “I was a depressed woman in pain 24/7 -- I was willing to do anything,” said Ms. Goldman.
Dr. Leone said that Ms. Goldman was “vertically unstable and her back was collapsing like a slinky.” Ms. Goldman suffered from degenerative disc disease and lumbar spinal stenosis, which is a narrowing of the spinal canal that causes pinched nerves and shooting leg pain. Without surgery, there was a risk of paralysis.
Because Dr. Leone did not know when the spinal implant would get FDA approval, he didn’t mention it to any of his patients for fear of creating false hope. On April 21, Dr. Leone met with the Goldmans and told them a new surgical implant was available to treat Ms. Goldman’s condition. She was a prime candidate for the procedure because she needed a two-level fusion, meaning two discs were damaged. The surgery would only require the device to be implanted into the front of the spine, cutting surgical time in half, lowering the risk of complications and reducing recovery time to three months instead of six. When presented with the new surgical option, a surprised and elated Ms. Goldman said, “Sign me up.” Dr. Leone scheduled the surgery at Glen Cove Hospital three days later. Entering through the abdomen, the surgery first required the expertise of general surgeon Kevin Harrison, MD to reposition internal organs to clear the way for Dr. Leone to implant the device into the front of the spine, removing two discs and fusing three vertebrae together (L4, L5 and S1). The surgery took approximately 2 ½ hours. “The spinal implant offers new technology with curved anchoring plates that is easy to insert and allows me to work effectively through a small incision,” said Dr. Leone. The anchoring plate insertion is safer, protecting the major veins and arteries during the procedure.” In addition, The ROI-A™ implant design minimizes exposure of the vertebral bodies and leaves no hardware protruding in the front of the spine, making mobility safer for patients and optimizing stability. Two weeks after surgery, Ms. Goldman said, “I feel 115 percent better. Before, sleeping and walking were unbearable and I was tired all the time.” Ten years ago, Ms. Goldman had been an avid runner and described herself as “super active.” While she is still in the recovery stage, she said she looks forward to performing seemingly simple tasks in the meantime. “I am looking forward to going to the supermarket by myself and putting away the groceries; that’s something I always needed help with. I want to take care of my house and family and continue to heal.” Ms. Goldman and her husband are planning a trip to Florida in the coming months, something that was impossible before the surgery because she could not sit for long periods of travel. In June, Ms. Goldman’s is also looking forward to her daughter’s high school graduation. “I feel very well. . . I’m a happy person,” said Ms. Goldman. “Dr. Leone kept me walking and I am a very, very lucky woman.” Contact: Betty Olt |
