Tops (Total Posterior Spine System)
Posted Date: Mar 3, 2021
- Investigator: Joseph Cheng
- Type of Study: Device
The purpose of this trial is 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. Patient will need to complete study procedures such as questionnaires, MRI, DEXA & X-rays throughout the study period. Patients will be randomized to the TOPS System or the TLIF during surgery. Study visits include screening, surgery, post-surgery, 6 weeks post-surgery, 3, 6, 12, 24, 36,48. & 60 months post-surgery. The total time in trial will be roughly 5 years.
Patients Diagnosed With (1) At Least Moderate Lumbar Spinal Stenosis, And (2) Grade 1 Spondylolisthesis (Or Retrolisthesis), And (3) Thickening Of The Ligamentum Flavum Or Scarring Of The Facet Joint Capsule.
Lumbar Spinal Stenosis, Spine, Transforaminal Lumbar Interbody Fusion
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