Clinical trials: Spinal Stenosis
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, Degenerative Spondylolisthesis
Assessing Safety of Cervical Spine Fusion With NMP®
The goal of this retrospective chart review study is to assess safety of NMP® in the treatment of cervical spine degenerative conditions by assessing the incidence and nature of AEs in follow-up (minimum of 90 days and up to 2…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis Cervical
- Trial name
- NCT07245940
- Testing
- Natural Matrix Protein (NMP) Fibers, Cervical interbody fusion
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Red Rock Regeneration Inc.
Degenerative Disc Disease, Spinal Stenosis
New Robotic Assistance System for Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- AQrate (NCT02558621)
- Testing
- AQrate Robotic Assistance System
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- KB Medical SA
Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1
Pedicle Osteotomy for Stenosis Trial
This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1, Neurogenic Claudication
- Trial name
- POST (NCT03381677)
- Testing
- Pedicle Lengthening Osteotomy with Altum® Device, Control
- Where
- United States
- Volunteers
- 344 people
- Sponsor
- Innovative Surgical Designs
Low Back Pain, Spondylolisthesis
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
Lumbar spinal fusion is commonly performed as a "last resort" in patients with chronic low back pain caused by degenerative changes and instability of the spine.
- Conditions
- Low Back Pain, Spondylolisthesis, Spinal Stenosis, Intervertebral Disc Displacement
- Trial name
- NCT00095095
- Testing
- Lumbar Interbody Fusion
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 102 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spinal Stenosis
Effects of X-STOP® Versus Laminectomy Study
To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire.
- Trial name
- EXELS (NCT00558129)
- Testing
- X-STOP®, Laminectomy
- Sponsor
- Medtronic Spine LLC
Spondylosis, Spinal Stenosis
A Prospective Study of NuCel® in Cervical Spine Fusion
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
- Conditions
- Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Disease
- Trial name
- NCT02381067
- Testing
- NuCel with Allograft Bone
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- NuTech Medical, Inc
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
Spinal Stenosis
Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
- Trial name
- NCT00534235
- Testing
- Decompression, Posterolateral Fusion and Implantation of Pedicle Screws, Implantation of coflex Interlaminar Technology
- Volunteers
- 322 people
- Sponsor
- Paradigm Spine
Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis
- Trial name
- FELIX (NCT01727752)
- Testing
- Decompression
- Where
- 13 sites in Netherlands
- Volunteers
- 386 people
- Sponsor
- Paradigm Spine
Degenerative Disc Disease, Spinal Stenosis
Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine
nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and…
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01968993
- Testing
- nanOss Bioactive - posterolateral gutter
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Pioneer Surgical Technology, Inc.
Spinal Stenosis
Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device
The purpose of this clinical study is to evaluate fusion of the facet joints in a prospective cohort of patients utilizing the VerteLoc facet fixation device in patients receiving lumbar laminectomy (L1-S1), without ancillary…
- Trial name
- NCT01892878
- Testing
- VerteLoc
- Where
- United States
- Sponsor
- VG Innovations, LLC
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Degenerative Disk Disease, Spinal Stenosis of Lumbar Region
Performance of Inductigraft in Spinal Fusion
This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of…
- Trial name
- APOLLO (NCT01452022)
- Testing
- Inductigraft
- Where
- 15 sites in Germany, Hungary and 3 more
- Volunteers
- 125 people
- Sponsor
- Baxter Healthcare Corporation
Degenerative Disc Disease, Spondylolisthesis
PMCF Neo Pedicle Screw and Cage Systems
The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Tumor
- Trial name
- NCT03956537
- Testing
- NEO Pedicle Screw System™, Neo Cage System™
- Where
- 2 sites in Germany, Spain
- Volunteers
- 150 people
- Sponsor
- Neo Medical SA
Lumbar Spinal Stenosis
Postmarket Registry for Evaluation of the Superion® Spacer
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).
- Trial name
- PRESS (NCT04087811)
- Testing
- Superion® Indirect Decompression System (IDS)
- Where
- 66 sites in United States
- Volunteers
- 1,674 people
- Sponsor
- Boston Scientific Corporation
Degenerative Disc Disease, Degenerative Spondylolisthesis
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT06000319
- Testing
- Natural Matrix Protein (NMP) Fibers, Lumbar interbody fusion, Cervical interbody fusion
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Induce Biologics USA Inc.
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
The MiDAS ENCORE Study
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having…
- Trial name
- NCT02093520
- Testing
- MILD Procedure, Epidural Steroid Injection
- Where
- 12 sites in United States
- Volunteers
- 302 people
- Sponsor
- Vertos Medical, Inc.
Spinal Cord Diseases
Comparison of Cervical Laminectomy to Laminoplasty
The objective of this study is to compare the clinical and radiographic outcomes of multi-level laminectomy to multi-level laminoplasty in the treatment of patients with cervical myelopathy or myeloradiculopathy.
- Trial name
- NCT01324622
- Testing
- Laminoplasty, laminectomy
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Synthes USA HQ, Inc.
Lumbar Spinal Stenosis, Spondylolisthesis
Post-market Study of the TOPS™ System
This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.
- Trial name
- NCT02234154
- Testing
- TOPS System
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Premia Spine