Clinical trials: Degenerative Lumbar Disease
Degenerative Disc Disease
Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
This is a retrospective clinical study (chart review) of patients who have previously undergone Transforaminal Lumbar Interbody Fusion or Posterior Lumbar Interbody Fusion surgery with the FlareHawk expandable interbody fusion…
- Trial name
- NCT04057235
- Testing
- FlareHawk Interbody Fusion System
- Where
- 3 sites in United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Integrity Implants Inc.
Spinal Injuries
Response Shift in Patient Expectations and Functional Outcome
The purpose of this study is to evaluate the results of elective lumbar spinal surgery as it relates to shifting patient expectations for outcome.
- Trial name
- NCT00289393
- Testing
- Perceived outcome by both patient and physician
- Where
- Canada
- Sponsor
- Sunnybrook Health Sciences Centre
Intervertebral Disc Displacement, Intervertebral Disc Degeneration
Lumbar Disc Space Height in Young Disc Herniation and Degeneration Patients
As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic intervertebral disc change in young adults holds high clinical relevance as a common structural cause of LBP.
- Conditions
- Intervertebral Disc Displacement, Intervertebral Disc Degeneration, Low Back Pain
- Trial name
- NCT02351206
- Testing
- x-ray, MRI
- Volunteers
- 389 people, healthy volunteers welcome
- Sponsor
- Jaseng Hospital of Korean Medicine
Degenerative Disc Disease
Comparative Analysis of Virtuos and Autograft in Lumbar Fusion
Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental…
- Trial name
- NCT05614284
- Testing
- Virtuos
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Orthofix Inc.
Degenerative Disc Disease, Facet Joint Syndrome
Intradiscal and Intra-articular Injection of Autologous Platelet-Rich-Plasma (PRP) in Patients With Lumbar Degenerative Disc Disease and Facet Joint Syndrome
Autologous Platelet-Rich-Plasma (PRP) represents a regenerative therapy that has gained remarkable ground in the field of orthopaedics in recent years.
- Trial name
- NCT04816747
- Testing
- Autologous PRP
- Volunteers
- 50 people
- Sponsor
- Stylianos Kapetanakis
Spondylosis, Spondylolisthesis
Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5
- Conditions
- Spondylosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT05238740
- Testing
- ViviGen®, rhBMP-2
- Where
- Switzerland
- Volunteers
- 168 people
- Sponsor
- Lindenhofgruppe AG
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.
Disc Disease Degenerative, Disk Degeneration
A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement.
- Conditions
- Disc Disease Degenerative, Disk Degeneration, Disc Disease Lumbar
- Trial name
- NCT03674190
- Testing
- Anterior Lumbar Interbody Fusion, Total Disc Replacement
- Where
- Sweden
- Sponsor
- Svante Berg
Degenerative Disc Disease, Spondylolisthesis
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00549913
- Testing
- NeoFuse, posterolateral spinal fusion with instrumentation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mesoblast, Ltd.
Lumbar Degenerative Disease, Lumbar Radiculopathy
Comparison of Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in Patients With Lumbar Disc Herniation
The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone…
- Conditions
- Lumbar Degenerative Disease, Lumbar Radiculopathy, Sciatic Leg Pain, Sciatic Nerve Compression
- Trial name
- NCT06615518
- Testing
- FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups, Microdiscectomy
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- University of Opole
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG
Osteopenia, Lumbar Spondylolisthesis
Denosumab vs Zoledronate After Lumbar Fusion
The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire…
- Trial name
- NCT05638399
- Testing
- Denosumab 60 mg/ml [Prolia], Zoledronate
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen People's Hospital
Low Back Pain, Degenerative Condition, Neurologic
Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation
The aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis.
- Trial name
- FIMFos (NCT06018155)
- Testing
- Spine surgery
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Degenerative Disc Disease, Chronic Low-back Pain
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.
- Trial name
- LOPAIN2 (NCT05508360)
- Testing
- PerQdisc Nucleus Replacement System
- Where
- 11 sites in Colombia, Costa Rica and 3 more
- Volunteers
- 72 people
- Sponsor
- Spinal Stabilization Technologies
Sciatica, Spinal Stenosis of Lumbar Region
Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg
The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the long-term results of prolotherapy are more effective than those of the current conventional treatment: epidural steroid injections (ESI).
- Conditions
- Sciatica, Spinal Stenosis of Lumbar Region, Degeneration of Lumbar or Lumbosacral Intervertebral Disc
- Trial name
- NCT01934868
- Testing
- prolotherapy solution of 20% dextrose, Epidural Steroid Injection
- Where
- Israel
- Volunteers
- 110 people
- Sponsor
- Hadassah Medical Organization
Degenerative Disc Disease
Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft
The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain.
- Trial name
- NCT06415123
- Testing
- MagnetOs Flex Matrix
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Research Source
Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study
The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions (IDD) and to obtain preliminary efficacy…
- Trial name
- NCT00693784
- Testing
- Biostat® Disc Augmentation System
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Spinal Restoration, Inc.
Arthrodesis
Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies
Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life.
- Trial name
- OTP (NCT05100732)
- Where
- France
- Volunteers
- 150 people
- Sponsor
- University Hospital, Strasbourg, France
Low Back Pain, Disk Herniated Lumbar
Predicting Outcomes After Lumbar Fusion for Degenerative Disease
The aim of the FUSE-ML study is to develop and externally validate a robust ML-based prediction tool based on multicenter data from a range of international centers that will provide individualized risk-benefit profiles tailored…
- Conditions
- Low Back Pain, Disk Herniated Lumbar, Spinal Stenosis Lumbar
- Trial name
- FUSE-ML (NCT05161130)
- Testing
- Lumbar Spinal Fusion
- Where
- 4 sites in Austria, France and 1 more
- Volunteers
- 1,115 people
- Sponsor
- Bergman Clinics
Lumbar Disc Disease, Lumbar Spine Degeneration
The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).
- Conditions
- Lumbar Disc Disease, Lumbar Spine Degeneration, Lumbar Spinal Stenosis
- Trial name
- 6MWT-DDD (NCT03977961)
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- Cantonal Hospital of St. Gallen