Clinical trials: Lumbar Degenerative Spinal Disease
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
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
Lumbar Spine Disease, Instabilities Lumbar
Registry for Evaluation of Lumbar Arthrodesis Sagittal alignmEnt
The study goal of RELApSE is to evaluate the relationships between radiological data and patients reported outcome. Restoration of Sagittal alignment and Pelvic Index (PI)-Lumbar Lordosis (LL) mismatch is closely associated with…
- Conditions
- Lumbar Spine Disease, Instabilities Lumbar, Lumbar Spine Instability
- Trial name
- RELAPSE (NCT05448092)
- Where
- 8 sites in Italy
- Volunteers
- 500 people
- Sponsor
- Unit of neurosurgery, Departement of Neurosciences, University of Torino
Degenerative Disc Disease
Trinity Elite in Lumbar Fusion
This prospective, post-market, open label clinical study is designed to examine the lumbar fusion rate at 24 months post operative in subjects who have undergone a lumbar fusion surgery using Trinity Elite with or without local…
- Trial name
- NCT02969616
- Testing
- Trinity Elite
- Volunteers
- 300 people
- Sponsor
- Orthofix Inc.
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
Degenerative Disc Disease, Spondylolisthesis
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Trial name
- NCT04416321
- Testing
- Surgery with the Keos Lumbar Interbody Fusion Device
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Invibio Ltd
Lumbar Degenerative Disc Disease
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.
- Trial name
- ATB (NCT01323387)
- Testing
- Interbody Fusion
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Synthes USA HQ, 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, Chronic Lower Back Pain
Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
The purpose of this study is to assess the safety and the efficacy of an hydrogel (double cross-link microgel - DXM) injection into the intervertebral disc (IVD) space in patients with painful lumbar degenerative disc disease…
- Conditions
- Degenerative Disc Disease, Chronic Lower Back Pain, Discogenic Pain, Intervertebral Disc Degeneration
- Trial name
- DXM gel (NCT04727385)
- Testing
- Double Crosslink Microgel
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Gelmetix
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