Researchers at Marshall University's Joan C. Edwards School of Medicine in Huntington, West Virginia, have joined a clinical study to test a new device designed to give lumbar fusion patients more motion after spinal surgery.
Marshall is one of just 30 health care organizations in the United States to test the device, known as the TOPS System. The TOPS system is a mechanical device that is designed to restore the spine's motion in all directions after spinal fusion procedures.
The clinical trial is operated by the Food Drug Administration and is sponsored by Premia Spine, the TOPS system manufacturer.
The developers of the TOPS System hope that their product will reduce pain and restore a better quality of life for individuals living with moderate to severe lumbar spinal stenosis.
"Most individuals living with spinal stenosis face surgery to alleviate uncomfortable symptoms," said Dr. Faisal Jahangiri, CNIM, D. ABNM, FASNM, of AXIS Neuromonitoring in Richardson, Texas.
AXIS Neuromonitoring offers comprehensive intraoperative neuromonitoring services during surgery to improve patients' post-procedure outcomes.
What Is Spinal Stenosis?
Spinal stenosis is a condition that causes narrowing of the spinal column, which can eventually put pressure on the spinal cord. As a result of the pressure, most patients living with the condition experience pain, numbness, muscle weakness, balance problems and difficulty moving or limited range of movement.
The traditional surgical remedy for spinal stenosis is lumbar surgery, in which affected vertebrae are fused together.
"Spinal fusion helps to stabilize areas affected by spinal stenosis," Jahangiri said.
But, stabilization often comes at a cost: decreased range of motion.
"Post-procedure, patients may not move quite as easily as they did before their surgery," Jahangiri said.
About the TOPS Device
The TOPS device is designed to sit between titanium plates inserted in the spine. Researchers developing the project believe this will allow for more movement – a full range of motion – versus fusing vertebrae.
Researchers from Marshall's department of neurosurgery say the device will also put less pressure on nearby vertebrae, reducing the risk of future surgeries. They are also hopeful that the TOPS system will help treat others living with different spinal conditions.
Effects of Surgery
While the spinal fusion procedure is a conventional surgery for those living with spinal stenosis, the procedure is not without its risks. In addition to decreased range of motion after the procedure, some patients can experience numbness, tingling and muscle weakness as a result of the procedure, too.
One cause of numbness related to the spinal stenosis procedure is the positioning of the patient during surgery.
In an AXIS case study, a 59-year-old man was admitted to the hospital with spinal stenosis, experiencing left neck pain, arm pain and numbness in the thumb.
During the patient's spinal surgery, AXIS intraoperative neuromonitoring technologists noted a decrease in the patient's right upper Somatosensory Evoked Potentials (SSEP).
SSEPs test the electrical signals of sensation going from the body to the brain. They show functionality of the nerves that connect to the spinal cord and if they can send and receive sensory information.
"If an SSEP shows a change in nerve function, patients may be left unable to feel touch, limbs, know where their limbs are, and identify shape or weight of an object by holding it," Jahangiri said.
In the case of the 59-year-old man, the technologist immediately informed the surgeon and the anesthesiologist of the change in the patient. To preserve patient nerve function, the patient's right arm was repositioned. Significant improvement in the patient's SSEP was noted.
Without intraoperative neuromonitoring, the changes in nerve function would have gone unnoticed, causing ischemia, damage such as stretching or compression of the nerves, and brachial plexus injury could have occurred.
These conditions could have left the patient living with muscle weakness, numbness, severe pain, burning sensations, tingling and other uncomfortable side effects.
The Herald Dispatch. School of Medicine testing new spinal device for stenosis. 18 July 2019.
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