Investigational Device a Possible Solution for Back and Leg Pain
About 500,000 people in the U.S. suffer from spinal stenosis which causes severe pain and numbness in the legs. A clinical study being conducted at Pottstown Memorial Medical Center might give patients hope for relief.
Spinal stenosis is a narrowing of the spinal canal caused by arthritis that puts pressure on spinal nerves and causes pain, cramping or weakness in the legs or buttocks. It’s most common for people over 50 and can be debilitating, hindering the ability to walk. An investigational device is being studied as a possible solution.
The device functions like a support column to open the passageways that contain the spinal cord and nerves, reducing the compression on the nerves and providing pain relief.
The device is approved by the U.S. Food and Drug Administration (FDA) and is in clinical trial at 35 sites across the country to determine its long-term safety and effectiveness.
“With this study, the FDA wants to know whether the device is as effective as other devices for spinal stenosis, in terms of benefits to the patients and complications,” explains Dr. William Cano, M.D., of Performance Spine and Sports Physicians in Pottstown. “If it is, then the FDA will make it available for all physicians to offer it to their patients.”
Local sites for the study, which involves 350 patients nationwide, include Pottstown Memorial Medical Center, Abington Memorial Hospital and Warren Hospital in Phillipsburg, NJ.
Half of the patients who qualify for the study will receive the device and half will receive another device. Patient outcomes will be evaluated in six follow-up exams over the course of 24 months after surgery. The study, which began in 2009, is enrolling patients and will run until June 2011.
According to Dr. Cano, when inserting a more traditional device into a patient’s body, a physician must make a three-inch incision in the back. With the new investigational device, which is about the size of a small paper clip, the incision is only about one quarter-inch. The advantages of the smaller incision are less damage to muscle and less bleeding.
“Another advantage of using this type of device is that it’s not necessary to remove any bone from the spine while performing the procedure,” says Dr. Cano. “A laminectomy procedure, which is another option for solving back and leg pain, involves removal of bone and can leave the spine in an unstable condition.”
The procedure for inserting the device takes about 30-45 minutes and is done on an out-patient basis.
“If these devices are successful, a patient can walk without pain,” Dr. Cano adds, “and for many patients, that’s something they haven’t been able to do in years. Another thing that patients notice after a successful procedure is that they have more strength in their legs and they need less pain medication.”
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