St. David's Round Rock Medical Center will host a study of a new procedure that could provide patients with alternative to spinal fusions.
The Total Posterior Spine System, or TOPS, is an artificial joint implanted into the spine that can help patients with severe back and leg pain. For patients, like those in serious car accidents, who are unable to treat their back problems through rehab, a spinal fusion can be the best option.
Although neurosurgeons consider fusions to be the “gold standard” for dealing with severe spinal issues, one drawback to the procedure is a decrease in motion between the two vertebrae that have been fused together.
The decreased level of motion can cause the vertebrae to absorb more motion, leading to increased wear and potential need for additional fusions. Dr. Carl Lauryssen, director of neurosurgery at St. David's Round Rock Medical center, said the study will help surgeons identify whether the device can “preserve motion” in the spine.
We know that spinal fusions work ‘ he said. “But the whole concept TOPS device is to preserve movement and prevent adjacent (spinal) segments from becoming a problem.”
The trial will compare how patients respond to either the TOPS or a spinal fusion, tracking their recovery for five to seven years. Premia Spine, which manufactures the TOPS device, is funding the study, which could cost between $30 million and $40 million.
If Lauryssen and his team find that the TOPS procedure has comparable results to a traditional spinal fusion, the device could receive Federal Drug Administration approval for use in the United States. The procedure has already undergone extensive testing in Europe and Israel.
“The FDA requires that (the procedure) is not only safe, but that the outcomes are as good as with a fusion, and that there are no new complications,” Lauryssen said.
Lauryssen noted St. David's Round Rock Medical Center was chosen among 30 other hospitals to conduct the study, because the FDA had confidence in the facility's ability to conduct the trial at the “highest level of scrutiny.”
He said his team will not only screen the patients and conduct the procedures, they will also track the results of each procedure through extensive follow-up appointments and MRI testing to check on how each device is holding up.
Ultimately, Lauryssen said, the TOPS device would provide patients with an alternative to a traditional spinal fusion. He said the procedure could reduce costs to the patient over time by reducing the “domino effect” of one spinal fusion following another due to decreased motion between the fused vertebrae.
“But with either procedure, patients will receive a high-quality level of care that will help them,” he said.