Clinical trials: Lumbar Degenerative Disease
Early Lumbar Disc Degeneration
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.
- Trial name
- NCT01158924
- Testing
- Intradiscal rhGDF-5
- Where
- 3 sites in Australia
- Volunteers
- 40 people
- Sponsor
- DePuy Spine
Degeneration of Lumbar Intervertebral Disc
OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
The purpose of this study was to collect data to demonstrate the safety and effectiveness of the OptiMesh 1500S to contain and reinforce bone graft materials in patients with Degenerative Disc Disease (DDD) whose condition…
- Trial name
- OLIF (NCT00764491)
- Testing
- Structural Allograft Spacer, OptiMesh 1500S
- Where
- 11 sites in United States
- Volunteers
- 156 people
- Sponsor
- Spineology, Inc
Intervertebral Disc Disease
Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage
The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal…
- Trial name
- NCT03018392
- Testing
- Stryker Tritanium Spinal System
- Volunteers
- 20 people
- Sponsor
- Bone and Joint Clinic of Baton Rouge
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.
Lumbar Degenerative Disease, Shared Decision Making
Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases.
Background: Shared decision making (SDM) is a patient-centered and evidence-based model of clinical decision making. The feature of SDM is that clinicians work together with patients to plan the most appropriate and practical…
- Conditions
- Lumbar Degenerative Disease, Shared Decision Making, Patient Decision Aids, Evidence-based Medicine
- Trial name
- NCT03679494
- Testing
- Shared decision making support tool
- Where
- Taiwan
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University
Degenerative Disc Disease, Lumbar Spondylosis
Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
The main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease.
- Conditions
- Degenerative Disc Disease, Lumbar Spondylosis, Low Back Pain
- Trial name
- NCT03484403
- Testing
- Lumbar back brace, Back school
- Volunteers
- 61 people
- Sponsor
- Dallas VA Medical Center
Spondylosis, Cervical Spondylosis
ViBone in Cervical and Lumbar Spine Fusion
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
- Conditions
- Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus
- Trial name
- NCT03425682
- Testing
- ViBone
- Where
- 4 sites in United States
- Volunteers
- 118 people
- Sponsor
- Elutia Inc.
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
TXA in Spinal Fusion
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels.
- Trial name
- NCT04272606
- Testing
- Tranexamic Acid, Saline Solution, Visual Acuity Exam
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- Catherine R. Olinger
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 Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Intervertebral Disc Degeneration
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
The purpose of this study is to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- Trial name
- MASTERS-D2 (NCT02617563)
- Testing
- Minimally invasive lumbar fusion
- Where
- 27 sites in Argentina, Austria and 15 more
- Volunteers
- 361 people
- Sponsor
- Medtronic Spinal and Biologics
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, Intervertebral Disc Disease
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD).
- Conditions
- Degenerative Disc Disease, Intervertebral Disc Disease, Low Back Pain
- Trial name
- Disc_allo (NCT01860417)
- Testing
- Allogenic Mesenchymal Stromal Cells, Mepivacaine
- Where
- 2 sites in Spain
- Volunteers
- 24 people
- Sponsor
- Red de Terapia Celular
Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
- Trial name
- NCT01110967
- Where
- 3 sites in Czechia, Slovakia and 1 more
- Volunteers
- 40 people
- Sponsor
- Medtronic Spinal and Biologics