Los Angeles-based The Anand Spine Group will study Premia Spine's TOPS System in a FDA Investigational Device Exemption study.
Neel Anand, MD, founded Anand Spine Group and serves as clinical professor of surgery and director of spine trauma at Cedars-Sinai Spine Center in Los Angeles.
Here are five highlights:
1. The study will evaluate the TOPS System as the first posterior arthroplasty device intended to treat degenerative Grade I spondylolisthesis and spinal stenosis, against traditional lumbar fusion.
2. Intended to restore spine motion in all directions, the TOPS System avoids locking vertebrae as done in a fusion. Europe commercially approved the TOPS System five-plus years ago.
3. The Anand Spine Group represents one of 30 spine centers participating in the study.
4. In the study, patients will undergo the TOPS System surgery or lumbar spinal fusion, with a 67 percent change of receiving the system surgery.
5. Dr. Anand and other researchers will assess Oswestry Disability Index, visual analog scale, neurologic function, device integrity and reoperation rates, among other outcomes.
"We are very excited to be selected as investigators in the TOPS System study because it offers a unique opportunity for patients who meet the study's criteria to potentially receive a motion-preserving device for the surgical treatment of degenerative spondylolisthesis and spinal stenosis," said Dr. Anand.