Clinical trials: Lumbar Spinal Canal Stenosis
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
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
Assessing Superion Clinical Endpoints vs. Decompression
PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct…
- Trial name
- ASCEND (NCT03048955)
- Testing
- Superion® IDS, Direct decompression Surgery
- Where
- 5 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- VertiFlex, Incorporated
Degenerative Lumbar Spinal Stenosis
Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Post-operative Functional Incapacity (BDYNCLIN)
Degenerative Lumbar Spinal Stenosis (LSS) is an extremely common condition affecting more than 102 million people each year. It is a narrowing of the spinal canal in the lower back.
- Trial name
- BDYNCLIN (NCT04407338)
- Testing
- B-DYN, Conventional Bolted fusion (with or without cage)
- Where
- 2 sites in France
- Volunteers
- 216 people
- Sponsor
- Quanta Medical
Spinal Stenosis
Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar…
- Trial name
- NCT01316211
- Testing
- Implantation of coflex™ after surgical decompression, Surgical decompression
- Where
- 8 sites in Germany
- Volunteers
- 246 people
- Sponsor
- Paradigm Spine
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.
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.
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.
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
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
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
Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Spinal Stenosis, Scoliosis
- Trial name
- NCT06532968
- Testing
- ORION spinal lamina cover
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Orion Biotech Inc.
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
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, Spondylolisthesis
Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis Lumbar
- Trial name
- NCT03884283
- Testing
- FIBERGRAFT BG Matrix
- Where
- 9 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Prosidyan, Inc.
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.
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
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.
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
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Kore Fiber PLF Study
This is a prospective, randomized controlled trial evaluating Kore Fiber® versus autograft in adults undergoing posterolateral lumbar fusion (PLF).
- Conditions
- Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT07868510
- Testing
- Kore Fiber, Autologous bone graft
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Kolosis Bio, LLC