Clinical trials: Spinal Stenosis
Lumbar Spinal Stenosis
Postmarket Registry for Evaluation of the Superion® Spacer
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).
- Trial name
- PRESS (NCT04087811)
- Testing
- Superion® Indirect Decompression System (IDS)
- Where
- 66 sites in United States
- Volunteers
- 1,674 people
- Sponsor
- Boston Scientific Corporation
Degenerative Disc Disease, Spinal Stenosis
New Robotic Assistance System for Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- AQrate (NCT02558621)
- Testing
- AQrate Robotic Assistance System
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- KB Medical SA
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.
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
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 Cord Diseases
Comparison of Cervical Laminectomy to Laminoplasty
The objective of this study is to compare the clinical and radiographic outcomes of multi-level laminectomy to multi-level laminoplasty in the treatment of patients with cervical myelopathy or myeloradiculopathy.
- Trial name
- NCT01324622
- Testing
- Laminoplasty, laminectomy
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Synthes USA HQ, Inc.
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Spinal Stenosis
Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc…
- Trial name
- NCT01485289
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Rachiotek LLC
Lumbar Spinal Stenosis, Spondylolisthesis
Post-market Study of the TOPS™ System
This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.
- Trial name
- NCT02234154
- Testing
- TOPS System
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Premia Spine
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.
Spondylolisthesis
XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.
- Trial name
- NCT01024699
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- NuVasive
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, Lumbar Disc Herniation
Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery
This multicenter, randomized, subject- and evaluator-blinded, active-controlled, non-inferiority clinical trial was conducted to evaluate the efficacy and safety of Collabarrier®, a collagen-based adhesion barrier, compared to…
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Epidural Fibrosis, Postoperative Adhesion
- Trial name
- NCT07153822
- Testing
- Collagen-based adhesion barrier, Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier
- Where
- 6 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- DALIM TISSEN Co., Ltd.
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
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.
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
Spinal Stenosis
Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion
To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.
- Trial name
- NCT03041896
- Testing
- coflex® Interlaminar Technology
- Volunteers
- 5,050 people
- Sponsor
- Paradigm Spine
Degenerative Disc Disease, Spinal Stenosis
OssDsign® Spine Registry Study ("Propel")
The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients…
- Trial name
- NCT05329129
- Testing
- OssDsign® Catalyst
- Where
- 16 sites in United States
- Volunteers
- 450 people
- Sponsor
- OssDsign
Spinal Stenosis
Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device
The purpose of this clinical study is to evaluate fusion of the facet joints in a prospective cohort of patients utilizing the VerteLoc facet fixation device in patients receiving lumbar laminectomy (L1-S1), without ancillary…
- Trial name
- NCT01892878
- Testing
- VerteLoc
- Where
- United States
- Sponsor
- VG Innovations, LLC
Cervical Stenosis, Spondylolisthesis
Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures
The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.
- Conditions
- Cervical Stenosis, Spondylolisthesis, Cervical Radiculopathy, Cervical Disc Disorder
- Trial name
- NCT04684901
- Testing
- AlloWrap® Amniotic Membrane
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AlloSource