Clinical trials: Stenosis, Spinal
Degenerative Disc Disease, Spondylolisthesis
Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion
The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Stenosis
- Trial name
- NCT02317185
- Testing
- genex bone graft with bone graft, autogenous bone graft
- Where
- 2 sites in United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Spine Wave
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Degenerative Disc Disease, Spondylolisthesis
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00549913
- Testing
- NeoFuse, posterolateral spinal fusion with instrumentation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mesoblast, Ltd.
Spinal Stenosis, Lumbar Region With Neurogenic Claudication
Assessing Superion Clinical Endpoints vs. Decompression
PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct…
- Trial name
- ASCEND (NCT03048955)
- Testing
- Superion® IDS, Direct decompression Surgery
- Where
- 5 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- VertiFlex, Incorporated
Low Back Pain
Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System
The zLOCK Facet Stabilization System is a fixation device intended to provide posterior stability in the lumbar spine fusion procedure.
- Trial name
- NCT05266521
- Testing
- zLOCK Facet Stabilization System
- Where
- 2 sites in Germany, Italy
- Volunteers
- 80 people
- Sponsor
- ZygoFix
Lumbar Spinal Stenosis
Effects of X-STOP® Versus Laminectomy Study
To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire.
- Trial name
- EXELS (NCT00558129)
- Testing
- X-STOP®, Laminectomy
- Sponsor
- Medtronic Spine LLC
Intervertebral Disc Disease, Intervertebral Disc Degeneration
Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
- Conditions
- Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis
- Trial name
- NCT02023372
- Testing
- NuCel with Autograft
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- NuTech Medical, Inc
Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Spinal Stenosis, Scoliosis
- Trial name
- NCT06532968
- Testing
- ORION spinal lamina cover
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Orion Biotech Inc.
Scarring, Spinal Stenosis
dHACM in Lumbar Decompression and Microdiscectomy Surgery
Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.
- Conditions
- Scarring, Spinal Stenosis, Herniated Disc
- Trial name
- NCT02300909
- Testing
- Lumbar Decompression Surgery, Microdiscectomy Surgery, Dehydrated Human Amnion/Chorion Membrane (dHACM)
- Where
- United States
- Volunteers
- 143 people
- Sponsor
- MiMedx Group, Inc.
Lumbar Spinal Stenosis
Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer
The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one…
- Trial name
- NCT01156675
- Testing
- FLEXUS(TM) Interspinous Spacer, XSTOP® Interspinous Spacer
- Where
- United States
- Volunteers
- 215 people
- Sponsor
- Globus Medical Inc
Degenerative Changes, Stenosis
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared…
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT01873586
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- SeaSpine, Inc.
Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis, Discopathy
- Trial name
- NCT06320899
- Testing
- SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium, SpineShape System IV straight rod stiff
- Where
- 2 sites in Switzerland
- Volunteers
- 126 people
- Sponsor
- SpineSave AG
Spinal Fusion, Spinal Stenosis
Spine Registration Using 3D Scanning
The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.
- Conditions
- Spinal Fusion, Spinal Stenosis, Scoliosis, Spondylolisthesis
- Trial name
- NCT05195580
- Testing
- Optical 3D Scanner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Advanced Scanners Inc.
Cervical Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1.
- Conditions
- Cervical Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT01097486
- Testing
- NeoFuse, Allograft
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Mesoblast, Ltd.
Lumbar Spinal Stenosis
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis.
- Trial name
- NCT00401518
- Testing
- Non-randomized ACADIA® Facet Replacement System, Randomized ACADIA® Facet Replacement System, Randomized Instrumented posterolateral fusion (PLF)
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Globus Medical Inc
Lumbar Spinal Stenosis, Spondylolisthesis
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the lower part of the back. This causes discomfort in the legs when standing or walking because of pressure on the spinal nerves.There are…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT01455805
- Testing
- Minuteman Fusion Implant, surgical decompression
- Where
- 4 sites in United Kingdom
- Volunteers
- 48 people
- Sponsor
- Spinal Simplicity LLC
Intervertebral Disc Disease, Spondylolisthesis
PASS OCT® Post-market Clinical Follow-up
Prospective, multicenter non comparative and observational study (post-market clinical follow-up). Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
- Conditions
- Intervertebral Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Neoplasms
- Trial name
- NCT02931279
- Testing
- PASS OCT® Spinal System
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Medicrea International
Spinal Lumbar Stenosis, Claudication, Intermittent
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
- Trial name
- LB2CT01 (NCT05587465)
- Testing
- Lobster Device
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Diametros Medical srl
SPINAL Fracture, Vertebral Fractures
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients…
- Conditions
- SPINAL Fracture, Vertebral Fractures, Spinal Stenosis, Kyphosis
- Trial name
- NCT06153511
- Testing
- Robot assisted spinal transpedicular fixation
- Where
- Spain
- Volunteers
- 13 people
- Sponsor
- Cyber Surgery S.L.
Low Back Pain
Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study
ZygoFix has developed a system consisting of zLOCK Facet Fusion System. The zLOCK Facet Fusion System is intended for single level stabilization of a spinal motion segment to promote bonny fusion of the joint.
- Trial name
- NCT04229316
- Testing
- zLOCK Facet Stabilization System
- Where
- Hungary
- Volunteers
- 24 people
- Sponsor
- ZygoFix