Clinical trials: Disc Disease Degenerative
Degenerative Disc Disease
Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain
The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back…
- Trial name
- NCT01290367
- Testing
- Single Dose MPCs Injection, Single injection of saline solution, Single injection of hyaluronic acid
- Where
- 14 sites in United States, Australia
- Volunteers
- 100 people
- Sponsor
- Mesoblast, Ltd.
Degenerative Disc Disease
Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With TM-Ardis
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a…
- Trial name
- NCT02170558
- Testing
- TM- Ardis implant and Metal Reduction CT software
- Where
- United States
- Sponsor
- Zimmer Biomet
Degenerative Lumbar Disc Disease
Advanced XLIF Monitoring Pilot Study
Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been demonstrated, it is hypothesized that more information may be gathered if a greater section of the motor neural pathway was…
- Trial name
- NCT02192112
- Where
- 2 sites in United States
- Volunteers
- 57 people
- Sponsor
- NuVasive
Cervical Disc Degeneration
Real World Data Collection on the Synergy Cervical Disc
This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with…
- Trial name
- NCT05305430
- Testing
- Synergy Cervical Disc System
- Where
- Australia
- Volunteers
- 200 people
- Sponsor
- Synergy Spine Solutions
Lumbar Degenerative Disc Disease
Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)
The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.
- Trial name
- NCT01294007
- Testing
- PureGen Osteoprogenitor Cell Allograft, Autograft bone
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Alphatec Spine, 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 Disc Disease
Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease
Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on…
- Trial name
- AMSC-DSD-001 (NCT03827096)
- Testing
- Suspension of human autologous MSC 3P in 1.5 ml
- Volunteers
- 10 people
- Sponsor
- Bioinova, s.r.o.
Lumbar Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Spinal Diseases
MAVERICK™ Total Disc Replacement- Pivotal Study
The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, with overall…
- Trial name
- NCT00635843
- Testing
- MAVERICK™ Disc, LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
- Where
- 32 sites in United States
- Volunteers
- 577 people
- Sponsor
- Medtronic Spinal and Biologics
Cervical Intervertebral Disc Degeneration
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
- Trial name
- NCT01832818
- Testing
- NuNec Cervical Disc
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Pioneer Surgical Technology, Inc.
Spinal Stenosis, Spondylolisthesis
RAMP Study: A Study Comparing Two Lumbar Fusion Procedures
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format.
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- RAMP (NCT01716182)
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Baxano Surgical, Inc.
Degenerative Disc Disease
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device.
- Trial name
- NCT00389597
- Testing
- Cervical Artificial Disc
- Where
- 24 sites in United States
- Volunteers
- 599 people
- Sponsor
- LDR Spine USA
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
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG
Degenerative Disc Disease
A Pilot Study of rhBMP-2/ACS With the INTERFIX™ Device for the AnteriorLumbar Interbody Fusion in Patients With Degenerative Disc Disease
The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.
- Trial name
- NCT01491451
- Testing
- rhBMP-2/ACS/INTERFIX™, Autogenous bone/INTERFIX™
- Volunteers
- 45 people
- Sponsor
- Medtronic Spinal and Biologics
Cervical Spondylosis, Cervical Radiculopathy
Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease
DTRAX Graft is used to relieve nerve pressure in the neck in order to provide relief for Cervical Degenerative Disc Disease. This study is being conducted to determine the effectiveness of the graft, and to find out whether or…
- Conditions
- Cervical Spondylosis, Cervical Radiculopathy, Cervical Degenerative Disc Disease
- Trial name
- NCT01616719
- Testing
- DTRAX Graft
- Where
- 2 sites in United States
- Sponsor
- Providence Medical Technology, Inc.
Cervical Degenerative Disc Disease
Investigation of the Simplify® Cervical Artificial Disc
This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical…
- Trial name
- NCT02667067
- Testing
- Simplify Disc, Anterior Cervical Discectomy & Fusion
- Where
- 16 sites in United States
- Volunteers
- 150 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Lumbar
Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF procedure.
- Trial name
- NCT00948831
- Testing
- Osteocel Plus
- Where
- 7 sites in United States
- Volunteers
- 51 people
- Sponsor
- NuVasive
Degenerative Disc Disease (DDD)
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
- Trial name
- HYDRAFIL-D (NCT06011551)
- Testing
- The ReGelTec HYDRAFIL™ System, Conservative Care Management
- Where
- 16 sites in United States, Canada
- Volunteers
- 225 people
- Sponsor
- ReGelTec, Inc.
Degenerative Disc Disease, Grade 1 Spondylolisthesis
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results…
- Trial name
- RAVINE (NCT02068729)
- Volunteers
- 131 people
- Sponsor
- K2M, Inc.