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, 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
Spinal Stenosis
Neurogenic Intermittent Claudication Evaluation Study
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from…
- Trial name
- NICE (NCT00905359)
- Testing
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Where
- 19 sites in Australia, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Medtronic Spinal and Biologics
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.
Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome
Efficacy of Pregabalin in Patients With Radicular Pain
The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.
- Conditions
- Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome, Spinal Stenosis, Herniated Disc
- Trial name
- NCT00908375
- Testing
- Pregabalin, Sugar Pill
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Northwestern University
Lumbar Spinal Stenosis
Vertos Mild - Post Market Patient Outcomes
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression.
- Trial name
- NCT01076244
- Testing
- Minimally Invasive Lumbar Decompression
- Where
- 2 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- The Center for Pain Relief, Inc.
Spinal Stenosis, Low Back Pain
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis.
- Trial name
- LESS (NCT01238536)
- Testing
- Epidural steroid with local anesthetic injection, Epidural local anesthetic injection, Epidural steroid injection
- Where
- 10 sites in United States
- Volunteers
- 400 people
- Sponsor
- University of Washington
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 Osteoarthritis, Spondylosis
Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively.
- Conditions
- Lumbar Osteoarthritis, Spondylosis, Lumbar Disc Disease, Spinal Stenosis
- Trial name
- NCT02700451
- Testing
- Ketorolac, Acetaminophen
- Where
- United States
- Volunteers
- 178 people
- Sponsor
- Hospital for Special Surgery, New York
Lumbar Spinal Stenosis
Epidural Lavage Study for Lumbar Stenosis
The purpose of this research is to find out if there are inflammatory biomarkers (also known as biological markers) in epidural space that can predict response to an epidural steroid injection.
- Trial name
- NCT03511053
- Testing
- Epidural Steroid Injection with Lavage
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Dallas VA Medical Center
Spinal Stenosis, Inflammation
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
The aim of the proposed study is to examine the effect of DEX on the inflammatory response in major surgery. More importantly, the investigators will correlate changes in the concentration of inflammatory mediators with…
- Trial name
- NCT01377623
- Testing
- Dexmedetomidine group
- Where
- 2 sites in United States
- Volunteers
- 66 people
- Sponsor
- NYU Langone Health
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
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
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.
Spinal Fusion Acquired, Spinal Stenosis
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Major lumbar spine surgery causes inflammation, soreness and swelling that can delay discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory effects.
- Conditions
- Spinal Fusion Acquired, Spinal Stenosis, Lesions of Lumbosacral Intervertebral Disc, Spinal Diseases
- Trial name
- DEXREDLOS (NCT00808665)
- Testing
- Dexmedetomidine, 0.9% Saline
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Vanderbilt University Medical Center
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
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.
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 Spondylolisthesis, Degenerative Disc Disease
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively…
- Conditions
- Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Radiculopathy
- Trial name
- ViviGen (NCT03733626)
- Testing
- ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system, Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Corewell Health East
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.