Spinal Stenosis Clinical Trial
Official title:
A Study To Evaluate The Safety And Effectiveness Of TOPS™ System In The Lumbar Spine
This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.
This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System. Patients who are scheduled to undergo spinal surgery as part of their medical treatment and comply with the study inclusion/exclusion criteria will be recruited. Patients will undergo standard surgical decompression prior to device implantation. For patients with two or three levels of disease, the TOPS System will be combined with the Versalink Fixation System. All study devices are CE marked. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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