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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
| Active, not recruiting |
NCT04542577 -
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
|
||
| Recruiting |
NCT04477447 -
PMCF Study on the Safety and Performance of CESPACE 3D
|
||
| Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
| Terminated |
NCT01461005 -
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
|
N/A | |
| Completed |
NCT00405691 -
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
|
Phase 3 | |
| Completed |
NCT00205101 -
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
|
||
| Enrolling by invitation |
NCT04204135 -
The Course of Hip Flexion Weakness Following LLIF or ALIF
|
||
| Recruiting |
NCT05238740 -
Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen®
|
N/A | |
| Not yet recruiting |
NCT02805985 -
Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
|
N/A | |
| Completed |
NCT02966639 -
Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
|
||
| Completed |
NCT02931279 -
PASS OCT® Post-market Clinical Follow-up
|
||
| Active, not recruiting |
NCT02057744 -
MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
|
||
| Completed |
NCT01711203 -
The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis
|
N/A | |
| Completed |
NCT00549913 -
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
|
Phase 1/Phase 2 | |
| Terminated |
NCT00254852 -
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
|
N/A | |
| Terminated |
NCT00095095 -
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
|
Phase 4 | |
| Active, not recruiting |
NCT03956537 -
PMCF Neo Pedicle Screw and Cage Systems
|
||
| Recruiting |
NCT05182489 -
Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages
|
N/A | |
| Completed |
NCT02884440 -
Transverse Abdominis Plane Block for Anterior Approach Spine Surgery
|
Phase 2 |