The Marshall University Joan C. Edwards School of Medicine was one of 30 health care organizations nationwide to participate in a FDA-controlled clinical trial to test an alternative to lumbar fusion surgery called the Total Posterior Spine (TOPS) system. It is the only clinical investigational site in the State of West Virginia for this study.
Back pain impact more adults in the United States at some point in life. The National Institute of Neurological Disorders and Stroke reports 80% of adults experience lower back pain at some point in their life. More of a quarter of adults report back pain in the past three months.
Lumbar spinal stenosis is a medical condition in which the spinal canal narrows and compresses the nerves and blood vessels in the level of the lumbar vertebrae. Spinal stenosis may also impact the cervical or thoracic region, in which it is known as cervical spinal stenosis or thoracic spinal stenosis. Lumbar spinal stenosis can cause pain in the low back or buttocks, abnormal sensations, and the absence of sensation (numbness) in the legs, thighs, feet or buttocks or loss of bladder and bowel control.
The study’s purpose is for the sponsor, Premia Spine, and the 30 sites (including Marshall) to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2-L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, 2) Grade 1 spondylolisthesis (or retrolisthesis), 3) thickening of the ligamentum flavum or scarring of the facet joint capsule. Success for this clinical trial will be assessed by means of a composite endpoint that measures improvement in reported outcomes and the absence of any major device related complications. The study commenced on 2017 and ends September 2023.
Patients who meet the study criteria are randomly placed into two groups—one undergoing surgery with TOPS System and the other lumbar spinal fusion—with 67% undergoing surgery with the Premia Spine device.
Marshall Health started its participation in the study in the summer of 2019. The medical school-originated regional health system in West Virginia entered the study as Nicolas Phan, MD noted “We hope this study provides us with the scientific data needed to support the continued use of technologies aimed to correct underlying spinal surgeries.”
Marshall is now recruiting patients for the study. The surgeries will be performed at the Cabell Huntington Hospital.
Established originally in the 1970s through Teague-Cranston Act, that authorized the creation of five new medical schools in conjunction with existing VA hospitals. The West Virginia legislature appropriated funding for the school in 1975. It has increased dramatically in size and scope of operation, with 250 physicians and 1,300 employees serving patients in West Virginia, Ohio, Kentucky and beyond. Today, the highly-qualified health care providers of Marshall University’s Joan C Edwards School of Medicine, collectively known as Marshall Health, care for patients at more than 40 locations throughout the region. Marshall is the largest most comprehensive provider group in the region. It is among the highest employers in the state.
Marshall Health is committed to be a research leader in the region. Their researchers and clinical investigators are making advancements in fields such as cancer, liver disease and pneumonia that impact people worldwide. Importantly, Marshall is addressing specific research initiatives important to the Appalachian region of America including irritable bowel syndrome, obesity and addiction research (opioids). Marshall research includes dozens of centers and institutes covering different therapeutic areas.
In the recent local news David Odell, administrator of Marshall Health’s Department of Neuroscience notes, “We’ve got a really good team who have proven themselves in the past that we can really make a difference with these studies.” Odell continued, “Research is extremely important. It’s how we get better. We realize how important that is and how it can only make us better and be able to care for even better the residents of this state and people who may want to travel here.” Participation in this latest study in addition to all the others is indicative of quality in research.
Premia Spine and TOPS™ System
The TOPS System is a mechanical implant device that replaces the bony and soft tissues removed during spinal decompression surgery. This type of surgery is performed as a treatment for lumbar spinal stenosis (narrowing of the spinal canal), spondylolisthesis (slipped disc) and for facet joint arthrosis/cysts. The TOPS System is designed for use at a single level between L2 through L5 — the segments most commonly affected by spinal stenosis. It can also be combined with the Versalink™ Fusion System for multi-level disease between L1 and S1. For such patients the TOPS System serves as an important transitional segment between the rigid fixation of fusion and disease-free spine segments.
Call to Action: Do you live in the West Virginia region and have lower back pain associated with Lumbar spinal stenosis? If so, you might consider at least learning more about this study. Are you interested in partnering with Marshall Health to access the high quality research centers in this region of the United States? Contact their research department. For those interested in exploring intellectual property assets, they have a Technology Transfer office.