Clinical trials: Fusion of Spine, Lumbar Region
OsteoFlo HydroFiber
OsteoFlo HydroFiber Ambispective Evaluation
The goal of this observational, ambispective study is to collect real world patient outcomes to characterize the safety and effectiveness of OsteoFlo HydroFiber when used to promote fusion in the lumbar spine.
- Trial name
- NCT07784673
- Testing
- OsteoFlo HydroFiber
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- SurGenTec LLC
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 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.
Single Level Posterolateral Spinal Fusion
Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion
The hypothesis is that Aastrom TRC autologous bone marrow tissue "grafts" can be safely used to promote bone healing as part of a single level posterolateral spine fusion surgical procedure.
- Trial name
- NCT00797550
- Testing
- Bone Repair Cells (BRCs), Autologous bone graft
- Volunteers
- 2 people
- Sponsor
- Vericel Corporation
Fusion of Spine, Sacroiliac; Fusion
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
This study is a multi-center, observational, prospective and retrospective data collection study
- Trial name
- FUSION (NCT07204288)
- Where
- 7 sites in United States
- Volunteers
- 500 people
- Sponsor
- Spinal Simplicity LLC
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 Disc Disease, Lumbar Disc Disease
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of…
- Conditions
- Degenerative Disc Disease, Lumbar Disc Disease, Spine Disease, Lumbar Spine Degeneration
- Trial name
- RESTORE (NCT06462729)
- Testing
- LDGraft, Allograft Bone
- Where
- 4 sites in United States, Australia
- Volunteers
- 40 people
- Sponsor
- Locate Bio Pty Ltd
Degenerative Disc Disease, Spinal Stenosis
Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine
nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and…
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01968993
- Testing
- nanOss Bioactive - posterolateral gutter
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Pioneer Surgical Technology, Inc.
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
Intervertebral Disc Degeneration
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal…
- Trial name
- FixedD3 (NCT06342765)
- Testing
- Pedicle fixation surgery
- Where
- 3 sites in France
- Volunteers
- 330 people
- Sponsor
- SPINEVISION SAS
Degenerative Disc Disease
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the…
- Trial name
- NCT00215319
- Testing
- Lumbar I/F with cage and pedicle screws
- Where
- 2 sites in United States
- Volunteers
- 139 people
- Sponsor
- DePuy Spine
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 Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF…
- Trial name
- MASTERS-D (NCT01143324)
- Testing
- MAST™ procedure
- Where
- 19 sites in Austria, Belgium and 12 more
- Volunteers
- 255 people
- Sponsor
- Medtronic Spinal and Biologics