Clinical trials: Lumbar Spine Disease
Lumbar Disc Herniation
A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation
A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or…
- Trial name
- NCT01283438
- Testing
- Barricaid, Standard of Care
- Where
- 21 sites in Austria, Belgium and 4 more
- Volunteers
- 554 people
- Sponsor
- Intrinsic Therapeutics
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.
Lumbar Spinal Stenosis
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
- Trial name
- PRESS2 (NCT04563793)
- Testing
- Superion™ IDS
- Where
- 23 sites in United States
- Volunteers
- 129 people
- Sponsor
- Boston Scientific Corporation
Lumbar Disc Herniation
A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation
The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.
- Trial name
- NCT01978912
- Testing
- KTP-001
- Where
- 10 sites in United States
- Volunteers
- 24 people
- Sponsor
- Teijin America, Inc.
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.
Spinal Stenosis
Neurogenic Intermittent Claudication Evaluation Study
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from…
- Trial name
- NICE (NCT00905359)
- Testing
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Where
- 19 sites in Australia, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Medtronic Spinal and Biologics
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 Disc Disease
Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic degenerative disc disease using an open…
- Trial name
- NCT01491386
- Testing
- rhBMP-2/ACS/LT-CAGE® Device, Autogenous Bone/LT-CAGE® Device
- Volunteers
- 279 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Disc Herniation, Degenerative Spinal Stenosis
CETIS-I (CEra Traction Improves Spine-I)
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and…
- Conditions
- Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction
- Trial name
- NCT05549596
- Testing
- Ceragem Master V6 Traction, Physical therapy with standard traction device
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Ceragem Clinical Inc.
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, Spondylolisthesis
Post-market Study of the TOPS™ System
This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.
- Trial name
- NCT02234154
- Testing
- TOPS System
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Premia Spine
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft…
- Conditions
- Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- STABILITY (NCT06355791)
- Testing
- Minuteman G5 Device
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- Spinal Simplicity LLC
Lumbar Degenerative Disc Disease
CARES Lumbar Artificial Disc Registry
The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.
- Trial name
- NCT02139527
- Testing
- Total Disc Replacement
- Volunteers
- 120 people
- Sponsor
- DePuy Spine
Degenerative Spinal Conditions
A Pre-market Study to Evaluate b.Bone for Posterolateral Fusion (b.Spine Clinical Trial).
Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or…
- Trial name
- NCT05906394
- Testing
- Posterolateral Fusion
- Where
- 2 sites in Germany, Italy
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Lumbar Disc Disease
Single Center Study Comparing MOBIS II ST vs MOBIS PEEK
Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1
- Trial name
- MOBIS_US (NCT02852187)
- Testing
- SIGNUS MOBIS PEEK Cage, SIGNUS MOBIS II ST Cage
- Where
- United States
- Sponsor
- Signus Medizintechnik GmbH
Degenerative Disc Disease, Degenerative Spondylolisthesis
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT06000319
- Testing
- Natural Matrix Protein (NMP) Fibers, Lumbar interbody fusion, Cervical interbody fusion
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Induce Biologics USA Inc.
Degenerative Disc Disease, Back Pain
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels.
- Trial name
- NCT00948532
- Testing
- biologic, Osteocel Plus
- Where
- 13 sites in United States
- Volunteers
- 104 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Chronic Low-back Pain
Safety Study for An Artificial Disc Nucleus Replacement to Treat Chronic Low Back Pain
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
- Trial name
- NCT04004156
- Testing
- PerQdisc® Nucleus Replacement Device.
- Where
- 4 sites in Belgium, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- Spinal Stabilization Technologies
Osteoporosis
Transition From Alendronate to Romosozumab (AMG 785)
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated…
- Trial name
- NCT01588509
- Testing
- Romosozumab
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Amgen
Lumbar Disc Herniation
Effect of Decompression With and Without ELDOA in Lumber Disc Protrusion Patients
The study will be conducted to determine the effects of spinal decompression with and without ELDOA in patients of lumbar disc protrusion.
- Trial name
- ELDOA (NCT04930523)
- Testing
- Elongation Longitudinaux Avec Decoaption Osteo Articulaire, Decompression
- Where
- Pakistan
- Volunteers
- 20 people
- Sponsor
- Aqua Medical Services (Pvt) Ltd