Spondylolisthesis Clinical Trial
Official title:
A Study to Evaluate the Safety and Effectiveness of the Premia Spine TOPS(Total Posterior Spine) System.
The study will primarily look at the effectiveness of the TOPS (Total Posterior Spine) System when used in patients with lumbar spine stenosis (narrowing of the spinal canal) who would normally be candidates for spinal fusion.
This study is being conducted in order to evaluate the TOPS™ SP System from Premia Spine (referred to as "TOPS™ System" or "TOPS"). The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from degenerative spondylolisthesis, and spinal stenosis. Facet arthrosis is the inflammation and enlargement of the facet joints. Degenerative spondylolisthesis refers to abnormal and excessive movement of the vertebrae, causing pain in the lower back and legs. Spinal stenosis is a condition where compression of nerves produces symptoms of pain, numbness and tingling in the legs. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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