Clinical trials: Lumbar Spondylosis
Spondylolisthesis, Retrolisthesis
A Study Evaluating 3-Level OLIF Spine Fusion
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic…
- Conditions
- Spondylolisthesis, Retrolisthesis, Degenerative Disc Disease
- Trial name
- NCT03896347
- Testing
- ViBone®, Demineralized Bone Matrix, Bone Morphogenetic Protein
- Sponsor
- Elutia Inc.
Low Back Pain, Leg Pain
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal…
- Conditions
- Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00405691
- Testing
- "TOPS System" - Total Posterior Arthroplasty Implant
- Where
- 16 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Impliant, Ltd.
Intervertebral Disc Degeneration, Stenosis, Spinal
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk…
- Conditions
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity
- Trial name
- NCT05648474
- Testing
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Alphatec Spine, Inc.
Spondylosis, Cervical Spondylosis
ViBone in Cervical and Lumbar Spine Fusion
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
- Conditions
- Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus
- Trial name
- NCT03425682
- Testing
- ViBone
- Where
- 4 sites in United States
- Volunteers
- 118 people
- Sponsor
- Elutia Inc.
Degenerative Disc Disease, Spondylolisthesis
Pilot Study to Assess Safety/Preliminary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from…
- Trial name
- NCT00798902
- Testing
- Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules, Iliac crest autograft
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- BioSurface Engineering Technologies, 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
Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1
Pedicle Osteotomy for Stenosis Trial
This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1, Neurogenic Claudication
- Trial name
- POST (NCT03381677)
- Testing
- Pedicle Lengthening Osteotomy with Altum® Device, Control
- Where
- United States
- Volunteers
- 344 people
- Sponsor
- Innovative Surgical Designs
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral 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 posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Spondylolisthesis
Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
A prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion (L1 - S1).
- Trial name
- Spine1 (NCT03100032)
- Testing
- NVD-001, Standard of Care
- Where
- 12 sites in Belgium, Czechia and 1 more
- Volunteers
- 48 people
- Sponsor
- Novadip Biosciences
Spondylosis, Spondylolisthesis
Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5
- Conditions
- Spondylosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT05238740
- Testing
- ViviGen®, rhBMP-2
- Where
- Switzerland
- Volunteers
- 168 people
- Sponsor
- Lindenhofgruppe AG
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.
Intervertebral Disc Degeneration
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
The purpose of this study is to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- Trial name
- MASTERS-D2 (NCT02617563)
- Testing
- Minimally invasive lumbar fusion
- Where
- 27 sites in Argentina, Austria and 15 more
- Volunteers
- 361 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Spondylolisthesis
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Trial name
- NCT04416321
- Testing
- Surgery with the Keos Lumbar Interbody Fusion Device
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Invibio Ltd
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 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.
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
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
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
Disk Herniated Lumbar, Disc Disease Degenerative
Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages
Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion
- Conditions
- Disk Herniated Lumbar, Disc Disease Degenerative, Spondylolisthesis
- Trial name
- PRINTLIF (NCT05237908)
- Testing
- Transforaminal Lumbar Interbody Fusion
- Where
- Germany
- Volunteers
- 78 people
- Sponsor
- Aesculap AG