Clinical trials: Spinal Stabilization
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Low Back Pain
Wallis Stabilization System for Low Back Pain
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar…
- Trial name
- NCT00484458
- Testing
- Interspinous process and dynamic stabilization (Wallis System), Total Disc Replacement
- Where
- 11 sites in United States
- Volunteers
- 340 people
- Sponsor
- Zimmer Spine
Lumbar Degenerative Disc Disease, Lower Back Pain
Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine
Investigate the potential of tissue grafting that includes human mesenchymal stem cells in the repair and potential stabilization of the degenerative Lumbar disk and facet joint denovo and at the time of surgical reconstruction.
- Conditions
- Lumbar Degenerative Disc Disease, Lower Back Pain, Chronic Lower Back Pain
- Trial name
- NCT02529566
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Foundation for Spinal Research, Education and Humanitarian Care, Inc.
Degenerative Disc Disease(DDD)
Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease
The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF)…
- Trial name
- SECOND (NCT07721493)
- Testing
- Circumferential Cervical Fusion (CCF), Anterior Cervical Discectomy and Fusion
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- Providence Medical Technology, Inc.
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 Degenerative Disc Disease
Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease
The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels…
- Trial name
- NCT00878579
- Testing
- PDS System, Fusion
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Interventional Spine, Inc.
Spondylolisthesis, Neurologic Deficits
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
The purpose of the Post-Market Surveillance study is to evaluate safety.
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Trial name
- DSS (NCT01461005)
- Testing
- Dynamic Stabilization System (DSS)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Paradigm Spine
Degenerative Disc Disease
Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD
This study will evaluate the safety and effectiveness of a device called "Posterior Cervical Stabilization System or PCSS" when used along with posterior cervical fusion (PCF) in combination with anterior cervical discectomy and…
- Trial name
- FUSE (NCT04229017)
- Testing
- Anterior Cervical Discectomy and Fusion, Posterior Cervical Stabilization System (PCSS)
- Where
- 17 sites in United States
- Volunteers
- 236 people
- Sponsor
- Providence Medical Technology, Inc.
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
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
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Degenerative Spondylolisthesis, Pseudoarthrosis
Dynesys Spinal System Post Market 522 Study
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
- Trial name
- NCT01528072
- Testing
- Dynesys Spinal System
- Where
- 9 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Vertebral Compression Fracture
Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration
This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and…
- Trial name
- NCT07259811
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 2 sites in Germany
- Volunteers
- 10 people
- Sponsor
- Amber Implants B.V.
Degenerative Lumbar Spinal Stenosis
DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion
The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from…
- Trial name
- NCT00627497
- Testing
- Single-Level Posterior Decompression, DIAM Spinal Stabilization, Fusion
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spinal Stenosis
Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System
The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal…
- Trial name
- NCT00529997
- Testing
- Stabilimax NZ® Dynamic Spine Stabilization System
- Where
- 19 sites in United States
- Volunteers
- 480 people
- Sponsor
- Applied Spine Technologies
Spinal Stenosis, Spondylolisthesis
Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System
The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion…
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT02064855
- Volunteers
- 108 people
- Sponsor
- K2M, Inc.
Spinal Stenosis
Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar…
- Trial name
- NCT01316211
- Testing
- Implantation of coflex™ after surgical decompression, Surgical decompression
- Where
- 8 sites in Germany
- Volunteers
- 246 people
- Sponsor
- Paradigm Spine
Sciatica, Back Pain
Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.
- Trial name
- NCT00749996
- Testing
- DIAM™ Spinal Stabilization System, Herniectomy
- Where
- 19 sites in Belgium, Czechia and 6 more
- Volunteers
- 165 people
- Sponsor
- Medtronic Spinal and Biologics
Vertebral Compression Fracture
A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults.
- Trial name
- EXPAND (NCT07301749)
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 3 sites in France, Germany
- Volunteers
- 148 people
- Sponsor
- Amber Implants B.V.
Lumbar Degenerative Disc Disease
Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care
The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal Stabilization System in the treatment of moderate single-level lumbar degenerative disc disease.
- Trial name
- NCT00456378
- Testing
- DIAM™ Spinal Stabilization System, Conservative care
- Where
- 29 sites in United States
- Volunteers
- 311 people
- Sponsor
- Medtronic Spinal and Biologics