Clinical trials: Spinal Stenosis, Lumbar Region
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.
Lumbar Spinal Stenosis
The STEPS - Totalis™ Trial
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct…
- Trial name
- NCT02079038
- Testing
- Totalis, Comparator Surgical Procedure
- Where
- 19 sites in United States
- Volunteers
- 180 people
- Sponsor
- VertiFlex, Incorporated
Lumbar Spinal Stenosis
MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.
- Trial name
- NCT01082159
- Testing
- lumbar decompression
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Vertos Medical, Inc.
Degenerative Changes, Stenosis
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT02018445
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- SeaSpine, Inc.
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
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Spinal Simplicity LLC
Degenerative Lumbar Spinal Stenosis
Evaluation of the Efficacy and Safety of the FACET FIXation Implant.
This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.
- Trial name
- FACETFIX (NCT05645497)
- Testing
- Surgery with FACET FIXATION implants, Surgery with Pedicle Screw
- Where
- France
- Volunteers
- 116 people
- Sponsor
- SC Medica
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.
Spinal Stenosis, Spondylolisthesis
Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
The purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in…
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)
- Trial name
- NCT02171169
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Baxano Surgical, Inc.
Lumbar Spinal Stenosis
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal…
- Trial name
- MiDAS III (NCT01315145)
- Testing
- Percutaneous Lumbar Decompression, Epidural Steroid Injection
- Where
- 27 sites in United States
- Volunteers
- 138 people
- Sponsor
- Vertos Medical, Inc.
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
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.
Degenerative Changes, Stenosis
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared…
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT01873586
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- SeaSpine, Inc.
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
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.
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
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, Spondylolisthesis
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the lower part of the back. This causes discomfort in the legs when standing or walking because of pressure on the spinal nerves.There are…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT01455805
- Testing
- Minuteman Fusion Implant, surgical decompression
- Where
- 4 sites in United Kingdom
- Volunteers
- 48 people
- Sponsor
- Spinal Simplicity LLC
SPINAL Fracture, Vertebral Fractures
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients…
- Conditions
- SPINAL Fracture, Vertebral Fractures, Spinal Stenosis, Kyphosis
- Trial name
- NCT06153511
- Testing
- Robot assisted spinal transpedicular fixation
- Where
- Spain
- Volunteers
- 13 people
- Sponsor
- Cyber Surgery S.L.
Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis, Discopathy
- Trial name
- NCT06320899
- Testing
- SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium, SpineShape System IV straight rod stiff
- Where
- 2 sites in Switzerland
- Volunteers
- 126 people
- Sponsor
- SpineSave AG
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