Clinical trials: Disc Degeneration
Degenerative Disc Disease, Spondylolisthesis, Grade 1
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
- Trial name
- APROPOS (NCT02704689)
- Testing
- AccuLIF expandable TLIF cage
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- VB Spine, LLC
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
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
Lumbar Spine Degeneration
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical…
- Trial name
- TLIF (NCT01415908)
- Testing
- INFUSE Bone Graft, Iliac Crest Bone Graft
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
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
Intervertebral Disc Disease
Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage
The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal…
- Trial name
- NCT03018392
- Testing
- Stryker Tritanium Spinal System
- Volunteers
- 20 people
- Sponsor
- Bone and Joint Clinic of Baton Rouge
Symptomatic Cervical Disc Disease
Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).
- Trial name
- NCT00291018
- Testing
- Total Disc Replacement, ACDF
- Volunteers
- 368 people
- Sponsor
- Synthes USA HQ, Inc.
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
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.
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level…
- Trial name
- NCT02104141
- Testing
- ROIA Interbody Cage with VerteBRIDGE plating
- Volunteers
- 51 people
- Sponsor
- LDR Spine USA
Degenerative Disc Disease
A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
- Trial name
- NCT01124006
- Testing
- Intradiscal rhGDF-5, Water for injection
- Where
- 10 sites in United States
- Volunteers
- 24 people
- Sponsor
- DePuy Spine
Prolapsed Lumbar Disc, Prolapsed Cervical Disc
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and…
- Conditions
- Prolapsed Lumbar Disc, Prolapsed Cervical Disc, Intervertebral Disc Degeneration, Spondylolisthesis, Grade 1
- Trial name
- NCT01944345
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- Wenzel Spine
Degenerative Disc Disease
TXA in Spinal Fusion
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels.
- Trial name
- NCT04272606
- Testing
- Tranexamic Acid, Saline Solution, Visual Acuity Exam
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- Catherine R. Olinger
Degenerative Disc Disease
Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease
The purpose of this study is to learn whether an investigational device called the Activ-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine.
- Trial name
- NCT00589797
- Testing
- Activ-L Artificial Disc, ProDisc-L Total Disc Replacement or Charité Artificial Disc
- Where
- 17 sites in United States
- Volunteers
- 376 people, healthy volunteers welcome
- Sponsor
- Aesculap Implant Systems
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 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
Intradiscal rhGDF-5 Phase I/II Clinical Trial
Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease
- Trial name
- NCT00813813
- Testing
- Intradiscal rhGDF-5
- Where
- 8 sites in United States
- Volunteers
- 32 people
- Sponsor
- DePuy Spine
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
Intervertebral Disk Degeneration
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and…
- Trial name
- NCT00310440
- Testing
- P-15 Synthetic osteoconductive bone substitute, Autologous bone
- Where
- 12 sites in United States, Canada
- Volunteers
- 319 people
- Sponsor
- CeraPedics, Inc
Cervical Disc Herniation, Cervical Degenerative Disc Disease
Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion
The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.
- Conditions
- Cervical Disc Herniation, Cervical Degenerative Disc Disease, Cervical Spondylotic Myelopathy, Dysphagia
- Trial name
- NCT02539394
- Testing
- Methylprednisolone Acetate, Hemostatic Matrix Kit
- Volunteers
- 128 people
- Sponsor
- Hospital for Special Surgery, New York