Clinical trials: Degenerative Spine Disease
Degenerative Disc Disease, Cervical Spinal Instability
Cervical Interbody Implant Study
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
- Trial name
- NCT04689854
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- NuVasive
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Radiculopathy, Cervical, Myelopathy Cervical
Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease
The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function.
- Conditions
- Radiculopathy, Cervical, Myelopathy Cervical, Neurological Abnormality, Disc Disease
- Trial name
- NCT05971329
- Testing
- Cervical Fusion (ZetaFuse™ Bone Graft)
- Where
- 2 sites in Australia
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Zetagen Therapeutics, Inc
Degenerative Spondylolisthesis
Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
Ankasa Regenerative Therapeutics, Inc. (Ankasa) is developing ART352-L, a liposomal formulation of recombinant human Wnt3A protein, that is applied ex vivo, to harvested autologous bone grafts (autograft) to enhance the…
- Trial name
- NCT04378543
- Testing
- ART352-L
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Ankasa Regenerative Therapeutics, Inc.
Spinal Stenosis, Spondylolisthesis
Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System
The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion…
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT02064855
- Volunteers
- 108 people
- Sponsor
- K2M, 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 in Cervical Spine, Stenosis Cervical Spine
PMCF Study Fortilink-SC
This study is setup to be able to gather information on the safety and performance of the Fortilink-SC Ti cage of Paradigm Spine GmbH, up to one year after the surgery.
- Trial name
- NCT07834749
- Testing
- Cervical interbody fusion surgery (standalone)
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Spinal Fusion
Artoss Prospective Spine Registry Outcomes
This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.
- Trial name
- ASTRO (NCT04439032)
- Testing
- NanoBone Bone Graft Substitute
- Where
- 6 sites in United States
- Volunteers
- 330 people
- Sponsor
- Artoss Inc.
Lumbar Degenerative Disc Disease
Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care
The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal Stabilization System in the treatment of moderate single-level lumbar degenerative disc disease.
- Trial name
- NCT00456378
- Testing
- DIAM™ Spinal Stabilization System, Conservative care
- Where
- 29 sites in United States
- Volunteers
- 311 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Chronic Low-back Pain
Post Market Observational Trial for the PerQdisc Nucleus Replacement Device
PerQdisc PMCF1 is a post-market clinical follow-up observational trial to follow subjects receiving a PerQdisc spinal implant for a duration of 5 years.
- Trial name
- PMCF1 (NCT05105490)
- Testing
- PerQdisc
- Where
- Germany
- Sponsor
- Spinal Stabilization Technologies
Cervical Disc Disease, Degenerative Disc Disease
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
- Trial name
- NCT05258435
- Testing
- NuVasive Simplify Cervical Artificial Disc
- Where
- 10 sites in United States
- Volunteers
- 131 people
- Sponsor
- NuVasive
Cervical Degenerative Disc Disease
Real World Data Collection on the Synergy Disc
This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts.
- Trial name
- NCT06383949
- Testing
- Synergy Cervical Disc system
- Where
- Ireland
- Volunteers
- 50 people
- Sponsor
- Synergy Spine Solutions
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
Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease
This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.
- Trial name
- FORTE (NCT03761563)
- Testing
- Fortilink IBF System with TETRAfuse Technology
- Where
- 14 sites in United States
- Volunteers
- 15 people
- Sponsor
- Xtant Medical
Degenerative Disc Disease
Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
The purpose of this clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone dowel) as a method of facilitating spinal fusion in patients with degenerative disc disease.
- Trial name
- NCT01494493
- Testing
- rhBMP-2/ACS/allograft bone dowel, Autogenous bone/allograft bone dowel
- Volunteers
- 85 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Spinal Stenosis
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT00762723
- Testing
- Trinica Anterior Lumbar Plate System
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion
This is a prospective randomised study. Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion. Secondary objectives: Assess clinical outcome measurements.
- Trial name
- APPRAISET2 (NCT01018771)
- Testing
- Actifuse ABX, INFUSE, plus Mastergraft granules
- Where
- Australia
- Volunteers
- 100 people
- Sponsor
- Baxter Healthcare Corporation
Degenerative Disc Disease, Scoliosis
OLIF25™ /OLIF51™ Study
The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the…
- Trial name
- NCT02657421
- Testing
- Oblique Lateral Interbody Fusion
- Where
- 12 sites in United States, Belgium and 5 more
- Volunteers
- 168 people
- Sponsor
- Medtronic Spinal and Biologics
Cervical Disc Disease, Degenerative Disc Disease
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or…
- Trial name
- NCT05691231
- Testing
- NuVasive Simplify Cervical Artificial Disc
- Where
- 2 sites in United States
- Volunteers
- 158 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Spinal Stenosis
Burst Biologics Spinal Fusion Registry
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis
- Trial name
- NCT03064802
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- 4 sites in United States
- Volunteers
- 450 people
- Sponsor
- Burst Biologics