Clinical trials: Spinal Stenosis
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.
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, Thoracic Spinal Stenosis
Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion.
- Trial name
- NCT02063035
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Massachusetts General Hospital
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.
Degenerative Disc Disease, Trauma (Including Fractures)
BIO4 Clinical Case Study: Cervical Spine
The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.
- Conditions
- Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
- Trial name
- NCT03077204
- Testing
- 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)., Aviator Anterior Cervical Plating System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seton Healthcare Family
Spine Disease, Spinal Stenosis
CEUS For Intraoperative Spinal Cord Injury
Spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies.
- Conditions
- Spine Disease, Spinal Stenosis, Spinal Injury, Spinal Cord Diseases
- Trial name
- NCT05530798
- Testing
- Definity Perflutren Lipid Microsphere Ultrasound Contrast
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
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
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
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
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT00762723
- Testing
- Trinica Anterior Lumbar Plate System
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Spinal Stenosis
Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery
This is a prospective, single-arm post market study of patients to assess fusion in one or multiple continuous levels of the lumbosacral spine (L1-S1) using ViviGen Cellular Bone Matrix.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylosis, Spondylolisthesis
- Trial name
- NCT04007094
- Testing
- ViviGen Cellular Bone Matrix
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Ohio State University
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.
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
Lumbar Spinal Stenosis
Sterile Amniotic Fluid Filtrate Epidural Injection.
There is a large population of patients with lumbosacral radicular pain due to spinal stenosis who do not respond to physical therapy or oral medication management, yet wish to avoid spinal surgery or are simply not candidates…
- Trial name
- NCT04537026
- Testing
- Amniotic Fluid Allograft, Dexamethasone sodium phosphate
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- University of Utah
Spondylolisthesis, Stenosis
CopiOs Posterolateral Fusion Procedure
To compare radiographic data collection from patients undergoing instrumented PLF with CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical outcomes. Patients will serve as self controls.
- Trial name
- NCT01123850
- Testing
- Copios
- Where
- 6 sites in United States
- Volunteers
- 45 people
- Sponsor
- Zimmer Biomet
Lumbar Spinal Stenosis
Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
BACKGROUND: Lumbar spinal stenosis - known by patients as "arthritis of the spine" - is a condition that is very common; found in about 30% of older adults.
- Trial name
- NCT01943435
- Testing
- NSAIDs; adjunctive analgesics; adjunctive anti-depressants, Lumbar epidural injection, Joint Mobilizations (spine, sacroiliac, hip)
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- Michael Schneider, DC, PhD
Lumbar Spinal Stenosis
Lumbar Stenosis Outcomes Research (LUSTOR)
The primary objective of the proposed pilot study is to determine the efficacy of pregabalin in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients with neurogenic…
- Trial name
- LUSTOR (NCT00638443)
- Testing
- Pregabalin, Diphenhydramine
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Rochester
Lumbar Spinal Stenosis
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis.
- Trial name
- NCT00401518
- Testing
- Non-randomized ACADIA® Facet Replacement System, Randomized ACADIA® Facet Replacement System, Randomized Instrumented posterolateral fusion (PLF)
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Globus Medical Inc