Clinical trials: Lumbar Disc Degeneration
Degenerative Disc Disease (DDD)
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
- Trial name
- HYDRAFIL-D (NCT06011551)
- Testing
- The ReGelTec HYDRAFIL™ System, Conservative Care Management
- Where
- 16 sites in United States, Canada
- Volunteers
- 225 people
- Sponsor
- ReGelTec, Inc.
Degenerative Disc Disease
INDEPENDENCE Spacer for Lumbar Fusion
The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and…
- Trial name
- NCT02299323
- Testing
- INDEPENDENCE
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Globus Medical Inc
Degenerative Disc Disease
A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
The objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease.
- Trial name
- NCT05574543
- Testing
- AGA111
- Where
- 6 sites in China
- Volunteers
- 60 people
- Sponsor
- Angitia Biopharmaceuticals
Chronic Back Pain, Degenerative Disc Disease Lumbar
CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.
- Trial name
- ADAPT (NCT07137559)
- Testing
- CELZ-201-DDT
- Sponsor
- Creative Medical Technology Holdings Inc
Degenerative Disc Disease
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.
- Trial name
- NCT00758719
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Zimmer Biomet
Spinal Diseases
A-MAV™ Anterior Motion Segment Replacement
The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level…
- Trial name
- NCT00635934
- Testing
- A-MAV™ disc
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and…
- Trial name
- NCT02205138
- Testing
- ALLOB® cells with ceramic scaffold
- Where
- 8 sites in Belgium
- Volunteers
- 38 people
- Sponsor
- Bone Therapeutics S.A
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.
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.
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
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.
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
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
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.
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.
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