HUNTINGTON, W.Va. – Marshall University Joan C. Edwards School of Medicine is one of 30 health care organizations throughout the United States and the only one in West Virginia taking part in an FDA investigational device exemption (IDE) study, sponsored by Premia Spine, Ltd., to evaluate the efficacy and safety of the TOPS™ System compared to traditional lumbar fusion.
The TOPS™ System is a mechanical device that is designed to restore motion of the spine in all directions. Instead of permanently locking the two vertebrae with a fusion, the device allows the two vertebrae to continue moving.
“This movement puts less pressure on the adjacent vertebrae, which we predict will decrease the likelihood of future surgeries in the area,” said Nicolas Phan, M.D., a board-certified neurosurgeon at Marshall Health and associate professor in the department of neurosurgery at Marshall’s School of Medicine. “We hope this study provides us with the scientific data needed to support the continued use of technologies aimed to correct underlying spinal conditions.”
Patients who meet the study’s criteria will be randomly placed into two groups—one undergoing surgery with the TOPS™ System and the other lumbar spinal fusion – with 67% percent undergoing surgery with the Premia device. Both types of surgeries assume the same degree of risk, Phan explained.
Marshall is now recruiting patients for the study. To be eligible to participate, patients must be experiencing radiating leg pain, greater leg or buttock pain than back pain, severe pain after walking as little as 100 yards or two minutes, and/or pain that reduces when sitting, bending forward or leaning over a shopping cart. The surgeries will be performed at Cabell Huntington Hospital.
Participants will attend regularly scheduled study visits with Marshall Health physicians for ongoing assessment. For more information about the clinical trial or to schedule an assessment to see if you meet the criteria, please contact Dr. Phan at Marshall Neuroscience at 304-691-1787.
Study 1303949 has been approved by the Marshall University Institutional Review Board #1.
Date Posted: Monday, July 15, 2019