Clinical trials: Lumbar Degenerative Disease
Degenerative Disc Disease (DDD)
Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
This study will look at the result of using the FLD device as an artificial lumbar disc. The study will compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc.
- Trial name
- FLD (NCT00775801)
- Testing
- FLD, Control
- Where
- 14 sites in United States, Germany
- Volunteers
- 300 people
- Sponsor
- AxioMed Spine Corporation
Degenerative Disc Disease
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in…
- Trial name
- MSB-DR003 (NCT02412735)
- Testing
- Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture
- Where
- 48 sites in United States, Australia
- Volunteers
- 404 people
- Sponsor
- Mesoblast, Ltd.
Spondylolisthesis
XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.
- Trial name
- NCT01024699
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Chronic Low-back Pain
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
- Trial name
- LOPAIN1 (NCT04141098)
- Testing
- All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
- Where
- Paraguay
- Volunteers
- 9 people
- Sponsor
- Spinal Stabilization Technologies
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.
Degenerative Disc Disease
CHARITE™ vs. ALIF 5-Year Follow-up
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
- Trial name
- NCT00215332
- Testing
- CHARITE
- Where
- 10 sites in United States
- Volunteers
- 367 people
- Sponsor
- DePuy Spine
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing…
- Trial name
- PARTNER (NCT04679896)
- Testing
- MagnetOs Putty
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Kuros Biosurgery AG
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
Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.
- Trial name
- NCT01494454
- Testing
- rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System, Autograft/TSRH® or autograft/CD HORIZON® Spinal System.
- Volunteers
- 197 people
- Sponsor
- Medtronic Spinal and Biologics
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.
Degenerative Disc Disease
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
- Trial name
- XL TDR (NCT00927238)
- Testing
- XL TDR, Lumbar fusion surgery
- Where
- 17 sites in United States
- Volunteers
- 246 people
- Sponsor
- NuVasive
Degenerative Disk Disease
Study of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion
The goal of this study is to compare Bonglass-SS with titanum cage.
- Trial name
- NCT01439464
- Testing
- 4 CIS one-touch titanium cage, Bonglass-SS SSLPB
- Where
- 4 sites in South Korea
- Volunteers
- 86 people
- Sponsor
- BioAlpha Inc.
Degenerative Disc Disease
Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
This study is a post-marketing clinical follow-up study for MagnetOs Putty. MagnetOs Putty is a synthetic bone-like material which is routinely used by surgeons as a treatment for patients with degenerative disc disease who will…
- Trial name
- PROGRESS (NCT04128852)
- Testing
- MagnetOs Putty
- Sponsor
- Kuros Biosurgery AG
Spine Disease, Spinal Fusion
Validity and Accuracy of a Machine Learning Predictive Model in the Exploitation of Patients Related Outcomes in Spine Surgery
The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green…
- Conditions
- Spine Disease, Spinal Fusion, Surgery, Spine Degeneration
- Trial name
- DeepSurgery (NCT05166018)
- Testing
- SuMO Patient
- Where
- 2 sites in France
- Volunteers
- 174 people
- Sponsor
- Cortexx Medical Intelligence
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Kore Fiber PLF Study
This is a prospective, randomized controlled trial evaluating Kore Fiber® versus autograft in adults undergoing posterolateral lumbar fusion (PLF).
- Conditions
- Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT07868510
- Testing
- Kore Fiber, Autologous bone graft
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Kolosis Bio, LLC
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Disc Degeneration
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and one sham control in subjects with chronic low back…
- Trial name
- NCT03955315
- Testing
- IDCT
- Where
- 6 sites in Japan
- Volunteers
- 38 people
- Sponsor
- DiscGenics, Inc.
Degenerative Spine Disease
FIBERGRAFT Aeridyan Posterolateral Fusion Study
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level…
- Trial name
- NCT07059065
- Testing
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute, Demineralized Bone Matrix
- Where
- 5 sites in United States
- Volunteers
- 316 people
- Sponsor
- DePuy Synthes Products, Inc.
Degenerative Disc Disease
Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a TLIF procedure.
- Trial name
- NCT00947583
- Testing
- Osteocel Plus
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- NuVasive
Chronic Low-back Pain, Disc Degeneration
Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain
The purpose of this clinical study is to evaluate the safety, tolerability, and efficacy of CordSTEM-DD, an allogeneic umbilical cord-derived mesenchymal stem cell, as a cell-therapeutic drug in patients with chronic low back…
- Trial name
- NCT04530071
- Testing
- CordSTEM-DD (0.7 x 10^7 cells), CordSTEM-DD (2.1 x 10^7 cells)
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- CHABiotech CO., Ltd