Clinical trials: Spinal Stenosis
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
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.
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
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 Cord Injuries, Neuropathic Pain
Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury
The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain, Degenerative Disc Disease, Spinal Stenosis
- Trial name
- NCT06438471
- Testing
- EC5026 oral tablet
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- EicOsis Human Health Inc.
Spinal Stenosis
Intermittent Neurogenic Claudication Treatment With APERIUS®
The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius®…
- Trial name
- INCA (NCT00887744)
- Testing
- Aperius® Percutaneous Interspinous Spacer
- Where
- 12 sites in Belgium, Germany and 1 more
- Volunteers
- 162 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1
Evidence For Fusion In Spine With Orthoss®
This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).
- Conditions
- Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1, Lumbar Spinal Stenosis, Lumbar Disc Degeneration
- Trial name
- EFFISO (NCT03853356)
- Testing
- Orthoss
- Where
- 3 sites in Germany
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Geistlich Pharma AG
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
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.
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
Lower Back Pain of Disc Origin, Joint Facet Syndrome
Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease
This is an observational study designed as an extension of a prospective study conducted between 2012 and 2017. Patients who were originally enrolled in the initial study are being recontacted for follow-up assessment, including…
- Conditions
- Lower Back Pain of Disc Origin, Joint Facet Syndrome, Lumbar Canal Stenosis, Spinal Disease
- Trial name
- IntraLT (NCT07790328)
- Testing
- IntraSPINE
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Cousin Biotech
Lumbar Spinal Stenosis
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®
The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS).
- Trial name
- NCT00534092
- Testing
- X STOP® Interspinous Process Decompression System
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- Medtronic Spine LLC
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
Condition of Approval Study
This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population…
- Trial name
- COAST (NCT00517751)
- Testing
- X-STOP PEEK
- Where
- 23 sites in United States
- Volunteers
- 176 people
- Sponsor
- Medtronic Spine LLC
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 Spondylolisthesis, Lumbar Spinal Stenosis
LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis
The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band…
- Trial name
- NCT03115983
- Testing
- LimiFlex, Fusion Instrumentation, Decompression
- Where
- 28 sites in United States
- Volunteers
- 299 people
- Sponsor
- Empirical Spine, Inc.
Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion
The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00810212
- Testing
- PLF with autograft, PLF with NeoFuse
- Where
- United States
- Sponsor
- Mesoblast, Ltd.
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
Spinal Stenosis, Low Back Pain
Total Facet Arthroplasty System®(TFAS®) Clinical Trial
The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets following surgical removal.
- Conditions
- Spinal Stenosis, Low Back Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00418197
- Testing
- Total Facet Arthroplasty System® (TFAS®)
- Volunteers
- 450 people
- Sponsor
- Archus Orthopedics, Inc.