Clinical trials: Disc Degeneration
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.
Lumbar Disc Degenerative Disease
Drug Use Survey (DUS) of Triple Therapy (Methycobal (MBL)+ Myonal (MYO)+ Non-steroidal Anti-inflammatory Drags (NSAID)) on the Symptom Relief of Lumbar DDD in China
The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.
- Trial name
- NCT01299077
- Where
- 10 sites in China
- Volunteers
- 478 people
- Sponsor
- Eisai China Inc.
Cervical Degenerative Disc Disorder
Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized two-level Simplify Disc Investigational Device…
- Trial name
- NCT04980378
- Testing
- Simplify Disc
- Where
- 18 sites in United States
- Volunteers
- 291 people
- Sponsor
- NuVasive
Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis
Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle…
- Conditions
- Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Lumbar Spinal Deformity
- Trial name
- NCT03647501
- Testing
- Interbody cage (titanium), Interbody cage (PEEK)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Ohio State University
Degeneration of Lumbar Intervertebral Disc
OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
The purpose of this study was to collect data to demonstrate the safety and effectiveness of the OptiMesh 1500S to contain and reinforce bone graft materials in patients with Degenerative Disc Disease (DDD) whose condition…
- Trial name
- OLIF (NCT00764491)
- Testing
- Structural Allograft Spacer, OptiMesh 1500S
- Where
- 11 sites in United States
- Volunteers
- 156 people
- Sponsor
- Spineology, Inc
Cervical Degenerative Disc Disease
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or…
- Trial name
- NCT00432159
- Testing
- Cervical TDR, ACDF with plate
- Where
- 32 sites in United States, Australia and 1 more
- Volunteers
- 500 people
- Sponsor
- DePuy Spine
Degenerative Disc Disease, Spondylolisthesis, Grade 1
Safety and Efficacy of the CarboClear Pedicle Screw System
The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device…
- Trial name
- NCT02626624
- Testing
- Implantation of the CarboClear Pedicle Screw System
- Where
- 8 sites in United States, Israel
- Volunteers
- 57 people
- Sponsor
- CarboFix Orthopedics Ltd.
Intervertebral Disc Degeneration
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient.
- Trial name
- Duloxetine (NCT02535000)
- Testing
- Duloxetine
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Serviço de Anestesiologia de Joinville
Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
- Trial name
- NCT01110967
- Where
- 3 sites in Czechia, Slovakia and 1 more
- Volunteers
- 40 people
- Sponsor
- Medtronic Spinal and Biologics
Cervical Degenerative Disc Disease, Radiculopathy
An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.
- Conditions
- Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
- Trial name
- NCT03062657
- Testing
- PRESTIGE LP™ Cervical Disc
- Where
- 4 sites in United States
- Volunteers
- 25 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.
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.
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.
Lumbar Spondylolisthesis, Degenerative Disc Disease
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively…
- Conditions
- Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Radiculopathy
- Trial name
- ViviGen (NCT03733626)
- Testing
- ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system, Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Corewell Health East
Lumbar Degenerative Disc Disease, Spinal Stenosis
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.
- Conditions
- Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- NCT02070484
- Testing
- NuCel, Demineralized Bone Matrix
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- OhioHealth
Degenerative Disc Disease
INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level…
- Trial name
- ACDF (NCT00485173)
- Testing
- INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
- Where
- 16 sites in United States
- Volunteers
- 224 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Lumbar Spondylosis
Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
The main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease.
- Conditions
- Degenerative Disc Disease, Lumbar Spondylosis, Low Back Pain
- Trial name
- NCT03484403
- Testing
- Lumbar back brace, Back school
- Volunteers
- 61 people
- Sponsor
- Dallas VA Medical Center
Cervical Disc Degenerative Disorder
Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)
The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical…
- Trial name
- VCBM/ACDF (NCT02182843)
- Testing
- Cellentra VCBM
- Where
- 6 sites in United States
- Volunteers
- 81 people
- Sponsor
- Zimmer Biomet
Cervical Degenerative Disc Disease, Radiculopathy
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical…
- Conditions
- Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
- Trial name
- NCT00637156
- Testing
- PRESTIGE LP device at two adjacent levels, Bi-level fusion with ATLANTIS Cervical Plate System
- Where
- 29 sites in United States
- Volunteers
- 397 people
- Sponsor
- Medtronic Spinal and Biologics
Cervical Disc Disease
Clinical Outcomes Study Evaluating the Zero-P PEEK
This is a multi-center, prospective, outcomes study. In this study, the Zero-P PEEK implant will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3 and C7.
- Trial name
- NCT00945243
- Testing
- Zero-P
- Where
- 14 sites in United States
- Volunteers
- 11 people
- Sponsor
- Synthes USA HQ, Inc.