Clinical trials: Lumbar Degenerative Spinal Stenosis
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM 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 lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Lumbar Degenerative Disc Disease, Spinal Stenosis
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.
- Conditions
- Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- NCT02070484
- Testing
- NuCel, Demineralized Bone Matrix
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- OhioHealth
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
Low Back Pain, Lumbosacral Radiculopathy
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of…
- Conditions
- Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation
- Trial name
- NCT03514277
- Testing
- Exparel, Bupivacaine
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
Degenerative Lumbar Spinal Stenosis
DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion
The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from…
- Trial name
- NCT00627497
- Testing
- Single-Level Posterior Decompression, DIAM Spinal Stabilization, Fusion
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- Medtronic Spinal and Biologics
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral 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 posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
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
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
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 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
Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis
Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle…
- Conditions
- Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Lumbar Spinal Deformity
- Trial name
- NCT03647501
- Testing
- Interbody cage (titanium), Interbody cage (PEEK)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Ohio State University
Back Pain, Radiculopathy Lumbar
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery.
- Conditions
- Back Pain, Radiculopathy Lumbar, Degenerative Lumbar Spinal Stenosis
- Trial name
- NCT03801356
- Testing
- Selective Nerve Root Block
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- The Cleveland Clinic
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.
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
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 Stenosis, Lumbar Region, With Neurogenic Claudication
Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis
The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid.
- Trial name
- NCT01995461
- Testing
- bilateral transforaminal epidural steroid injections
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Marshfield Clinic Research Foundation
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.