Premia Spine enlisted 30 healthcare organizations in the U.S. to participate in an investigational device exemption study on the total posterior spine system.
Six things to know:
1. The trial is comparing the effectiveness of the total posterior spine system and transforaminal lumbar interbody fusion to stabilize a single lumbar level following surgical decompression.
2. The study, which began in January 2017, is examining around 266 patients diagnosed with at least moderate lumbar spinal stenosis, Grade 1 spondylolisthesis and thickening of the ligamentum flavum or scarring of the facet joint capsule.
3. Thirty healthcare organizations are participating in the study including Philadelphia-based Penn Medicine, Rochester, Minn.-based Mayo Clinic, Los Angeles-based Cedars-Sinai and Baltimore-based Johns Hopkins Medicine.
4. The TOPS system offers an alternative to lumbar fusion surgeries. It uses screws to connect the vertebrae to the device, rather than fusing the two vertebrae together.
5. A primary completion date is set for September 2020 with the study completion date estimated for September 2023.
6. Eighty percent of adults in the U.S. experience lower back pain at some point in their lives, which is the most common cause of job-related disability and a leading reason for missed work days, according to the National Institute of Neurological Disorders and Stroke.