Clinical trials: Degenerative Conditions of the Lumbar Spine
- Condition Degenerative Conditions of the Lumbar Spine
- Funder type Industry (pharma, biotech, devices)
Stenosis, Spondylolisthesis
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae)…
- Conditions
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT00254852
- Testing
- Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF)
- Where
- 6 sites in United States
- Volunteers
- 94 people
- Sponsor
- Exactech
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
A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
- Trial name
- NCT01771471
- Testing
- NuQu
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- ISTO Technologies, Inc.
Low Back Pain, Leg Pain
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal…
- Conditions
- Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00405691
- Testing
- "TOPS System" - Total Posterior Arthroplasty Implant
- Where
- 16 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Impliant, Ltd.
Lumbar Degenerative Disc Disease, Lower Back Pain
Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine
Investigate the potential of tissue grafting that includes human mesenchymal stem cells in the repair and potential stabilization of the degenerative Lumbar disk and facet joint denovo and at the time of surgical reconstruction.
- Conditions
- Lumbar Degenerative Disc Disease, Lower Back Pain, Chronic Lower Back Pain
- Trial name
- NCT02529566
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Foundation for Spinal Research, Education and Humanitarian Care, Inc.
Low Back Pain
Wallis Stabilization System for Low Back Pain
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar…
- Trial name
- NCT00484458
- Testing
- Interspinous process and dynamic stabilization (Wallis System), Total Disc Replacement
- Where
- 11 sites in United States
- Volunteers
- 340 people
- Sponsor
- Zimmer Spine
Lumbar Degenerative Disc Disease
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10…
- Trial name
- NCT01640977
- Testing
- Open PLIF (posterior lumbar interbody fusion), MAS PLIF
- Where
- 4 sites in United States
- Volunteers
- 67 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Degenerative Spondylolisthesis
XLIF Decade Plate System Study
The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04689880
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- NuVasive
Intervertebral Disc Displacement, Intervertebral Disc Degeneration
Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine
NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy, and of the adjacent degenerated disc, if…
- Trial name
- NDisc (NCT01640457)
- Testing
- NOVOCART® Disc plus, NOVOCART® Disc basic
- Where
- 10 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Tetec AG
Degenerative Conditions of the Lumbar Spine
AttraX® Putty vs. Autograft in XLIF®
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
- Trial name
- NCT02250248
- Testing
- AttraX Putty, Iliac Crest Bone Graft (ICBG)
- Where
- Brazil
- Volunteers
- 45 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
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
Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease
The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels…
- Trial name
- NCT00878579
- Testing
- PDS System, Fusion
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Interventional Spine, Inc.
Lower Back Pain
Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine
The safety and performance of the Elaspine™ Implant System in the treatment of lower back pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing clinical study (PMCS).
- Trial name
- NCT01323543
- Testing
- Elaspine™
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 40 people
- Sponsor
- Spinelab AG
Degenerative Disc Disease, Spondylolisthesis
MLX/XLX ACR Expandable Lumbar Interbody Implants
The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04420143
- Where
- 4 sites in United States
- Volunteers
- 109 people
- Sponsor
- NuVasive
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.
Low Back Pain
Wallis Mechanical Normalization System for Low Back Pain
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
- Trial name
- NCT00134537
- Testing
- Interspinous process and dynamic stabilization, Conservative Care
- Where
- 17 sites in United States
- Volunteers
- 300 people
- Sponsor
- Zimmer 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