Clinical trials: Spondylosis
Lumbar Spine Disease, Lumbar Spondylolisthesis
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar…
- Conditions
- Lumbar Spine Disease, Lumbar Spondylolisthesis, Lumbar Spine Instability, Lumbar Spondylosis
- Trial name
- SELECT (NCT05405374)
- Testing
- OSTEOAMP, Infuse
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Bioventus 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 Disc Disease, Spondylolisthesis
MLX/XLX ACR Expandable Lumbar Interbody Implants
The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04420143
- Where
- 4 sites in United States
- Volunteers
- 109 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
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) in 1 or 2 adjacent vertebral levels between L1 and S1.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00996073
- Testing
- Lumbar Interbody Fusion with Autograft, Lumbar Interbody Fusion with NeoFuse
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Mesoblast, Ltd.
Idiopathic Scoliosis, Spinal Curvatures
UNiD Rods Register
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD). This study aims to assess performance, clinical outcomes and safety
- Conditions
- Idiopathic Scoliosis, Spinal Curvatures, Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT02926404
- Testing
- UNiD Rods
- Where
- 13 sites in Belgium, France and 1 more
- Volunteers
- 743 people
- Sponsor
- Medicrea International
Herniated Disc, Radiculopathy
Slotted Hole Versus Fixed Hole C-Tek
The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.
- Conditions
- Herniated Disc, Radiculopathy, Spondylolysis
- Trial name
- NCT00585923
- Testing
- Fixed hole C-Tek™ Plate, Slotted hole C-Tek™ Plate
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Spondylolisthesis, Grade 1
Safety and Efficacy of the CarboClear Pedicle Screw System
The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device…
- Trial name
- NCT02626624
- Testing
- Implantation of the CarboClear Pedicle Screw System
- Where
- 8 sites in United States, Israel
- Volunteers
- 57 people
- Sponsor
- CarboFix Orthopedics Ltd.
Radiculopathy, Myelopathy
RHINE™ Cervical Disc Clinical Study: A Prospective Observational Study for Patients Requiring 1-2 Level C-spine Surgery
A Prospective, open label, multi-center observational study of patients requiring surgical treatment at one or two (contiguous) cervical spine levels.
- Conditions
- Radiculopathy, Myelopathy, Spondylosis, Herniated Nucleus Pulposus
- Trial name
- NCT02403453
- Testing
- Rhine Cervical Disc
- Volunteers
- 68 people
- Sponsor
- K2M, 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
Spondylolisthesis, Scoliosis
A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion.
- Conditions
- Spondylolisthesis, Scoliosis, Intervertebral Disc Disease
- Trial name
- NCT02225444
- Testing
- OsteoAMP
- Where
- 9 sites in United States
- Volunteers
- 42 people
- Sponsor
- Bioventus LLC
Spondylolisthesis
Aspen Spinous Process Fixation System for Use in PLF in Patients With Spondylolisthesis
The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System.
- Trial name
- NCT01560273
- Testing
- Aspen Spinous Process Fixation Device
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Herniated Disc
Bone Graft Materials Observational Registry
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
- Conditions
- Degenerative Disc Disease, Herniated Disc, Spinal Stenosis, Spondylolithesis
- Trial name
- APPROACH-001 (NCT00974623)
- Testing
- Bone graft substitute, autograft or allograft
- Where
- 14 sites in United States, Hungary and 1 more
- Volunteers
- 329 people
- Sponsor
- Baxter Healthcare Corporation
Radiculopathy, Spondylolisthesis
Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression
The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar…
- Conditions
- Radiculopathy, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- STRiDE (NCT01338766)
- Testing
- Decompression using the iO-Flex® system
- Where
- 14 sites in United States
- Volunteers
- 100 people
- Sponsor
- Baxano Surgical, Inc.
Spondylolisthesis
XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.
- Trial name
- NCT01024699
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Grade 1 Spondylolisthesis
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results…
- Trial name
- RAVINE (NCT02068729)
- Volunteers
- 131 people
- Sponsor
- K2M, Inc.
Lumbar Spinal Stenosis, Spondylolisthesis
Post-market Study of 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.
- Trial name
- NCT02234154
- Testing
- TOPS System
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Premia Spine
Degenerative Disc Disease, Spondylolisthesis
Study of Nucel for One and Two Level Lumbar Interbody Fusion
The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spondylosis
- Trial name
- NCT02808234
- Testing
- One or two level lumbar interbody fusion surgery, Nucel
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Degenerative Disc Disease, Spinal Stenosis
New Robotic Assistance System for Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- AQrate (NCT02558621)
- Testing
- AQrate Robotic Assistance System
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- KB Medical SA
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Degenerative Instability, Spondylolisthesis
Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instability
- Trial name
- NCT06265038
- Testing
- ReSpace TiCell Cage
- Where
- Hungary
- Volunteers
- 99 people
- Sponsor
- Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.