Clinical trials: Lumbar Spine Fusion
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
Spinal Fusion, Pain Management
PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery
The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery.
- Trial name
- NCT02985762
- Testing
- EXPAREL
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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 Spine Disease
FIBERGRAFT Aeridyan Posterolateral Fusion Study
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level…
- Trial name
- NCT07059065
- Testing
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute, Demineralized Bone Matrix
- Where
- 5 sites in United States
- Volunteers
- 316 people
- Sponsor
- DePuy Synthes Products, Inc.
Postoperative Pain Management
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL…
- Trial name
- FUSION (NCT03927911)
- Testing
- EXPAREL and Bupivacaine, Standard of Care
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Pacira Pharmaceuticals, 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.
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
Lumbar Spinal Stenosis Secondary to Other Disease
NanOss Bioactive With Autograft and Bone Marrow Aspirate in the Posterolateral Spine
The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler
- Trial name
- NCT02005341
- Testing
- nanOSS, Autograft
- Sponsor
- Pioneer Surgical Technology, Inc.
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 Conditions of the Lumbar Spine
AttraX® Putty vs. Autograft in XLIF®
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
- Trial name
- NCT02250248
- Testing
- AttraX Putty, Iliac Crest Bone Graft (ICBG)
- Where
- Brazil
- Volunteers
- 45 people
- Sponsor
- NuVasive
Degenerative Disc Disease
CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease
The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one level of the lumbar spine (either L4/L5…
- Trial name
- NCT00215306
- Testing
- CHARITÉ Artificial Disc, Anterior Interbody Fusion with BAK Cage
- Volunteers
- 304 people
- Sponsor
- DePuy Spine
Degenerative Disc Disease
Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion
The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.
- Trial name
- NCT05972616
- Testing
- Natural Matrix Protein (NMP)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Induce Biologics USA Inc.
Degenerative Disc Disease, Spondylolisthesis
Pilot Study to Assess Safety/Prelimary 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
- NCT00798239
- Testing
- Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules, Iliac crest autograft
- Where
- 5 sites in Canada
- Volunteers
- 24 people
- Sponsor
- BioSurface Engineering Technologies, Inc
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, Spinal Stenosis
SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Scoliosis
- Trial name
- NCT04566874
- Testing
- ALIF
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Camber Spine Technologies
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
Lumbar Facet Disease
A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
The purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine fixation to evaluate its effect on patients' level of pain, procedural complications and functional status.
- Trial name
- NCT00887835
- Testing
- PERPOS™ PLS
- Volunteers
- healthy volunteers welcome
- Sponsor
- Interventional Spine, Inc.
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Back Pain
- Trial name
- PROOF (NCT04679844)
- Testing
- MagnetOs Easypack Putty, Demineralized Bone Matrix or Fibers mixed with local autograft bone
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Kuros Biosurgery AG
Degenerative Lumbar Spondylolisthesis
Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
- Trial name
- NCT05961956
- Testing
- NVDX3
- Where
- Luxembourg
- Volunteers
- 5 people
- Sponsor
- Novadip Biosciences