Clinical trials: LUMBAR STENOSIS
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
Pseudoarthrosis, Spinal Stenosis
A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an…
- Conditions
- Pseudoarthrosis, Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)
- Trial name
- NCT01972256
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Baxano Surgical, Inc.
Lumbar Spinal Stenosis, Spondylolisthesis
Post-market Study of the TOPS™ System
The study is being conducted to evaluate look the TOPS System when used in patients with degenerative spondylolisthesis and lumbar spinal stenosis who would normally be candidates for spinal fusion.
- Trial name
- TOPS (NCT01933607)
- Testing
- TOPS System
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Premia Spine
Sciatica Acute, Lumbar Spinal Stenosis
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
The goal of this clinical trial is to learn if a modification to metaxalone 640 mg can reduce low back and leg pain. The participants will be 18 to 80 years old, healthy with newly occurring back or leg pain.
- Trial name
- NCT06157177
- Testing
- Metaxalone 640 mg Oral Tablet
- Where
- 24 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Primus Pharmaceuticals
Scarring, Spinal Stenosis
dHACM in Lumbar Decompression and Microdiscectomy Surgery
Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.
- Conditions
- Scarring, Spinal Stenosis, Herniated Disc
- Trial name
- NCT02300909
- Testing
- Lumbar Decompression Surgery, Microdiscectomy Surgery, Dehydrated Human Amnion/Chorion Membrane (dHACM)
- Where
- United States
- Volunteers
- 143 people
- Sponsor
- MiMedx Group, Inc.
Lumbar Spinal Stenosis
Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer
The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one…
- Trial name
- NCT01156675
- Testing
- FLEXUS(TM) Interspinous Spacer, XSTOP® Interspinous Spacer
- Where
- United States
- Volunteers
- 215 people
- Sponsor
- Globus Medical Inc
Spinal Stenosis
Neurogenic Intermittent Claudication Evaluation Study
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from…
- Trial name
- NICE (NCT00905359)
- Testing
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Where
- 19 sites in Australia, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spinal Stenosis, Intermittent Claudication
Investigating Superion™ In Spinal Stenosis
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of…
- Trial name
- NCT00692276
- Testing
- Superion™ Interspinous Spacer, X-STOP® IPD® Device
- Where
- 32 sites in United States
- Volunteers
- 391 people
- Sponsor
- Boston Scientific Corporation
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
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
Degenerative Lumbar Spinal Stenosis
A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion
This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion.
- Trial name
- NCT03532945
- Testing
- Bioactive Glass-Ceramic Spacer, Titanium cage
- Volunteers
- 62 people
- Sponsor
- BioAlpha Inc.
Lumbar Spinal Stenosis
Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System
The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal…
- Trial name
- NCT00529997
- Testing
- Stabilimax NZ® Dynamic Spine Stabilization System
- Where
- 19 sites in United States
- Volunteers
- 480 people
- Sponsor
- Applied Spine Technologies
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.
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
Lumbar Spinal Stenosis
The Vertos MILD™ Preliminary Patient Evaluation Study
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for…
- Trial name
- NCT00749073
- Testing
- Minimally Invasive Lumbar Decompression (MILD™)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Vertos Medical, Inc.
Lumbar Spinal Stenosis, Spondylolisthesis
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple…
- Trial name
- SPSI (NCT03754972)
- Testing
- Sagittal plane shear index (SPSI)
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Medical Metrics Diagnostics, Inc
Intervertebral Disc Disease, Intervertebral Disc Degeneration
Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
- Conditions
- Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis
- Trial name
- NCT02023372
- Testing
- NuCel with Autograft
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- NuTech Medical, Inc
Degenerative Disc Disease, Degenerative Spondylolisthesis
TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)
In recent years there has been an increase in interest from surgeons in the use of synthetic bone graft substitutes to avoid the need of sourcing allograft or iliac crest autograft for use in spinal fusion procedures.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT05114135
- Testing
- Osteo3 ZP Putty
- Where
- Hungary
- Volunteers
- 17 people
- Sponsor
- OssDsign
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
Lumbar Spinal Stenosis Secondary to Other Disease
NanOss Bioactive With Autograft and Bone Marrow Aspirate in the Posterolateral Spine
The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler
- Trial name
- NCT02005341
- Testing
- nanOSS, Autograft
- Sponsor
- Pioneer Surgical Technology, Inc.