Clinical trials: LUMBAR STENOSIS
Lumbar Spinal Stenosis
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
- Trial name
- PRESS2 (NCT04563793)
- Testing
- Superion™ IDS
- Where
- 23 sites in United States
- Volunteers
- 129 people
- Sponsor
- Boston Scientific Corporation
Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
A Pivotal Study of the Premia Spine TOPS™ System
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following…
- Trial name
- NCT03012776
- Testing
- Total Posterior Spine System (TOPS), Transforaminal Lumbar Interbody Fusion (TLIF)
- Where
- 36 sites in United States
- Volunteers
- 305 people
- Sponsor
- Premia Spine
Degenerative Disc Disease, Spinal Stenosis
Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01452516
- Testing
- nanOss Bioactive Bone void filler, Interbody FCage
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Pioneer Surgical Technology, Inc.
Degenerative Lumbar Spinal Stenosis
Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis
This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant.
- Trial name
- FFX® RCT (NCT06106061)
- Testing
- Decompression + FFX®, Decompression alone
- Volunteers
- 320 people
- Sponsor
- SC Medica
Spinal Stenosis
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent…
- Trial name
- In-Space (NCT00697827)
- Testing
- Interspinous Spacer device, Interspinous Process Distraction Device
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Synthes USA HQ, Inc.
Spinal Stenosis, Lumbar Region, Spondylolisthesis
Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults.
- Trial name
- NCT03968965
- Testing
- 3D MvIGS Spine Navigation, 2D Fluoroscopy
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- 7D Surgical Inc.
Intervertebral Disc Degeneration, Stenosis, Spinal
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk…
- Conditions
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity
- Trial name
- NCT05648474
- Testing
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Alphatec Spine, Inc.
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, Degenerative Spondylolisthesis
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00996073
- Testing
- Lumbar Interbody Fusion with Autograft, Lumbar Interbody Fusion with NeoFuse
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Mesoblast, Ltd.
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
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 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
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 Spondylolisthesis, Spinal Stenosis
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral…
- Trial name
- ENHANCE (NCT04483297)
- Testing
- AK1320 MS, Control
- Where
- 7 sites in Canada
- Volunteers
- 30 people
- Sponsor
- Asahi Kasei Therapeutics Corporation
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
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 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
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
The MOTION Study - Treatment of LSS With the MILD Procedure
Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional…
- Trial name
- NCT03610737
- Testing
- MILD Procedure, Conventional Medical Management (CMM)
- Where
- 18 sites in United States
- Volunteers
- 155 people
- Sponsor
- Vertos Medical, Inc.
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
Degenerative Disc Disease, Spondylolisthesis
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00549913
- Testing
- NeoFuse, posterolateral spinal fusion with instrumentation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mesoblast, Ltd.