Clinical trials: Lumbar Spine Degeneration
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
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.
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.
Lumbar Spine Degeneration
3Spine Lumbar Fusion Real World Evidence Study
This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF)…
- Trial name
- NCT04823858
- Testing
- Lumbar Interbody Fusion
- Where
- 20 sites in United States
- Volunteers
- 176 people
- Sponsor
- 3Spine
Degenerative Disease of the Lumbosacral Spine
Transforaminal Lumbar Interbody Fusion (TLIF)
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be…
- Trial name
- TLIF (NCT04073563)
- Testing
- Infuse™ Bone Graft (Infuse™), Intervertebral body fusion device and Medtronic posterior Fixation Systems
- Where
- 46 sites in United States, China
- Volunteers
- 600 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG
Lumbar Spine Stenosis, Lumbar Spine Degeneration
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research.
- Trial name
- NCT05452694
- Where
- 3 sites in United States
- Volunteers
- 235 people
- Sponsor
- OpalGenix, Inc
Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
A Pivotal Study of the Premia Spine TOPS™ System
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…
- Trial name
- NCT03012776
- Testing
- Total Posterior Spine System (TOPS), Transforaminal Lumbar Interbody Fusion (TLIF)
- Where
- 36 sites in United States
- Volunteers
- 305 people
- Sponsor
- Premia Spine
Degenerative Disc Disease, Spondylolisthesis, Grade 1
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
- Trial name
- APROPOS (NCT02704689)
- Testing
- AccuLIF expandable TLIF cage
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- VB Spine, LLC
Degenerative Disc Disease
Interbody Systems: Post Market Clinical Follow-up Study
This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF).
- Trial name
- NCT04911257
- Testing
- Cervical or Lumbar Spinal fusion
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- K2M, Inc.
Degenerative Disc Disease, Spinal Stenosis Lumbar
Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF).
- Conditions
- Degenerative Disc Disease, Spinal Stenosis Lumbar, Lumbar Spine Fusion, Spondylolisthesis
- Trial name
- NCT07775729
- Testing
- Allograft-derived growth factor (ProteiOS®), Standard of Care (SOC)
- Volunteers
- 280 people
- Sponsor
- Isto Biologics
Degenerative Disc Disease
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease…
- Trial name
- NCT02068768
- Testing
- Avenue® L Interbody Fusion System (LDR Spine)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- LDR Spine USA
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
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
Low Back Pain
Wallis Mechanical Normalization System for Low Back Pain
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
- Trial name
- NCT00134537
- Testing
- Interspinous process and dynamic stabilization, Conservative Care
- Where
- 17 sites in United States
- Volunteers
- 300 people
- Sponsor
- Zimmer Spine
Degenerative Disc Disease
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.
- Trial name
- NCT00758719
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Zimmer Biomet
Cervical Disc Disorder With Radiculopathy, Spinal Stenosis
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion…
- Conditions
- Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified
- Trial name
- NCT06365307
- Testing
- Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), Synthetic osteoplastic material based on β-TCP or bone autograft
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Histograft Co., Ltd.
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.
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
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.