The new procedure uses a flexible rasp-like device to remove bone and tissue to enlarge the opening, called the foramen, where nerves exit the spinal canal and extend to the limbs. The new device, called iO-Flex® allows the surgeon to remove just enough bone to open up the passageway and take the pressure off the nerve without removing so much bone that the spine becomes unstable.
The procedure offers an alternative to current techniques that depend on removing some of the facet joint, the vertebral bones surrounding the foramen. While such surgery, called laminectomy, has been effective for relieving pain, experience has shown that removing as little as 30 percent of the facet joint can result in spinal instability after the surgery, which over time can lead to degeneration, recurrence of pain, and eventually additional surgery.
“Our study shows that decompression using the minimally-invasive iO-Flex surgical guidewire technology system provided patients experiencing pain related to lateral spinal stenosis (LSS) with significantly improved clinical outcomes,” said study lead author Dr. Morgan Lorio of Advanced Orthopedics, “and it may represent an initial treatment strategy for patients with LSS.”
LSS is one of the most common causes of lower back pain. It usually starts in the lower back and often radiates down the legs causing numbness and weakness. If other treatments fail to improve the pain within three to six months, surgery may be indicated. Patients who are candidates for surgery experience unbearable pain that interferes with standing, walking, and sleeping. The pain gradually shortens the distance the person can walk, and neurological examination indicates progressing loss of function.
In the study, 63 patients with LSS, that did not respond to other treatments, underwent surgery aimed at decompressing the lumbar nerves causing the pain at 16 different spine centers. The average age of the 30 women and 33 men was nearly 65 years old.
Using the facet-sparing iOFlex technique, the surgeons enlarged the foramen to decompress the affected nerve or nerves and then followed the patients over two years. The patients were evaluated every six months after the surgery using five different measures of pain and function.
The six-month evaluation showed significant improvement compared to presurgery scores. The scores did not change at 12 months or 24 months, indicating that the pain relief and increased function patients experienced initially did not diminish over time.
There were two patients who had to be treated with additional surgery, one at the time of the original surgery when the surgeon realized the patient had a herniated disk and did not qualify for the study, and the second patient had a spinal defect that should have excluded the patient from the study. Other adverse events included tears of the membrane covering the spinal cord (dural tear), which occurred during the procedure but was not caused by the iO-Flex device.
Other complications included one patient who developed a urinary tract infection, a patient who developed a cyst or fluid-filled sac in the spinal membrane, and another patient whose surgeon was unable to complete the procedure and experienced continued pain as a result.
The researchers concluded that surgical decompression using the iO-Flex device improved all measured outcomes and the procedure using the device may be considered an initial surgery option in selected patients, although additional studies are warranted.
At Advanced Orthopedics, our goal is to help you feel better and heal faster. Combined with extensive experience, innovative technology, and advanced treatments we are able to provide you the complete array of treatment options, including advanced minimally invasive surgery, to allow you to consider all the treatment options for your condition. We are happy to review your MRI and discuss your options and answer all your questions to ensure you get the best treatment for you. For more information contact us at (407) 960-1717.