Clinical trials: Lumbar Spine Degenerative Changes
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.
Degenerative Disc Disease
A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
- Trial name
- NCT01771471
- Testing
- NuQu
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- ISTO Technologies, 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 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.
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
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
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
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
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.
Degenerative Disc Disease
Study of an Expandable Interbody Device for the Lumbar Spine
The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease.
- Trial name
- CALIBER (NCT02075554)
- Testing
- CALIBER
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Globus Medical Inc
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
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
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.
Low Back Pain
Wallis Stabilization System for Low Back Pain
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar…
- Trial name
- NCT00484458
- Testing
- Interspinous process and dynamic stabilization (Wallis System), Total Disc Replacement
- Where
- 11 sites in United States
- Volunteers
- 340 people
- Sponsor
- Zimmer Spine
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
Lumbar Degenerative Disc Disease
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease.
- Trial name
- MODEL (NCT05516992)
- Testing
- SB-01 For Injection
- Where
- 30 sites in United States
- Volunteers
- 417 people
- Sponsor
- Spine BioPharma, Inc
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
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.
Lumbar Degenerative Disc Disease
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10…
- Trial name
- NCT01640977
- Testing
- Open PLIF (posterior lumbar interbody fusion), MAS PLIF
- Where
- 4 sites in United States
- Volunteers
- 67 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Degenerative Spondylolisthesis
XLIF Decade Plate System Study
The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04689880
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- NuVasive