Clinical trials: Lumbar Disc Degeneration
Degenerative Disc Disease
Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients…
- Trial name
- NCT01494441
- Testing
- rhBMP-2/BCP, rhBMP-2/BCP/TSRH® Spinal System, Autograft/TSRH® Spinal System
- Volunteers
- 27 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Degenerative Spondylolisthesis
XLIF Decade Plate System Study
The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04689880
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- NuVasive
Degenerative Disc Disease
Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease
The goal of this study is to evaluate the safety and tolerability of TG-C in subjects with chronic discogenic lumbar back pain due to degenerative disc disease.
- Trial name
- NCT06144970
- Testing
- TG-C High Dose, TG-C Mid Dose, TG-C Low Dose
- Volunteers
- 24 people
- Sponsor
- Kolon TissueGene, Inc.
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.
Intervertebral Disc Displacement, Intervertebral Disc Degeneration
Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine
NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy, and of the adjacent degenerated disc, if…
- Trial name
- NDisc (NCT01640457)
- Testing
- NOVOCART® Disc plus, NOVOCART® Disc basic
- Where
- 10 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Tetec AG
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
PMCF Study Fortilink-TS Ti
This study is setup to be able to gather information on the safety and performance of the Fortilink-TS Ti cage of Paradigm Spine GmbH, up to one-year after the surgery.
- Trial name
- NCT07834736
- Testing
- Posterior lumbar interbody fusion surgery
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Degeneration of Lumbar Intervertebral Disc
Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lumbar interbody fusion in…
- Trial name
- NCT01491373
- Testing
- rhBMP-2/ACS/LT-CAGE® Device, Autograft/LT-CAGE® Device
- Volunteers
- 14 people
- Sponsor
- Medtronic Spinal and Biologics
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
Degenerative Disc Disease
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion
This is a prospective randomised study. Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion. Secondary objectives: Assess clinical outcome measurements.
- Trial name
- APPRAISET2 (NCT01018771)
- Testing
- Actifuse ABX, INFUSE, plus Mastergraft granules
- Where
- Australia
- Volunteers
- 100 people
- Sponsor
- Baxter Healthcare Corporation
Spondylolisthesis, Retrolisthesis
A Study Evaluating 3-Level OLIF Spine Fusion
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic…
- Conditions
- Spondylolisthesis, Retrolisthesis, Degenerative Disc Disease
- Trial name
- NCT03896347
- Testing
- ViBone®, Demineralized Bone Matrix, Bone Morphogenetic Protein
- Sponsor
- Elutia Inc.
Lumbar Spine Disease, Lumbar Spondylolisthesis
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar…
- Conditions
- Lumbar Spine Disease, Lumbar Spondylolisthesis, Lumbar Spine Instability, Lumbar Spondylosis
- Trial name
- SELECT (NCT05405374)
- Testing
- OSTEOAMP, Infuse
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Bioventus LLC
Degenerative Conditions of the Lumbar Spine
AttraX® Putty vs. Autograft in XLIF®
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
- Trial name
- NCT02250248
- Testing
- AttraX Putty, Iliac Crest Bone Graft (ICBG)
- Where
- Brazil
- Volunteers
- 45 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Scoliosis
OLIF25™ /OLIF51™ Study
The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the…
- Trial name
- NCT02657421
- Testing
- Oblique Lateral Interbody Fusion
- Where
- 12 sites in United States, Belgium and 5 more
- Volunteers
- 168 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease
Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)
This trial pretends to validate for clinical use a bioengineered product composed of mesenchymal stem cells produced by the Instituto de Biologia y Genetica Molecular (IBGM), Valladolid (MSV, which have already been approved by…
- Trial name
- MSV-DISC (NCT02440074)
- Testing
- Autologous bone marrow mesenchymal stem cells
- Sponsor
- Red de Terapia Celular
Intervertebral Disc Degeneration
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal…
- Trial name
- FixedD3 (NCT06342765)
- Testing
- Pedicle fixation surgery
- Where
- 3 sites in France
- Volunteers
- 330 people
- Sponsor
- SPINEVISION SAS
Intervertebral Disc Disease
Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous…
- Trial name
- NCT01513694
- Testing
- Instrumented posterolateral arthrodesis
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Red de Terapia Celular
Degenerative Disc Disease, Degenerative Spondylolisthesis
TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)
In recent years there has been an increase in interest from surgeons in the use of synthetic bone graft substitutes to avoid the need of sourcing allograft or iliac crest autograft for use in spinal fusion procedures.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT05114135
- Testing
- Osteo3 ZP Putty
- Where
- Hungary
- Volunteers
- 17 people
- Sponsor
- OssDsign
Degenerative Disc Disease, Back Pain
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels.
- Trial name
- NCT00948532
- Testing
- biologic, Osteocel Plus
- Where
- 13 sites in United States
- Volunteers
- 104 people
- Sponsor
- NuVasive
Degenerative Disc Disease
Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel
Degenerative disc disease (DDD) refers to a syndrome in which a degenerating disc causes chronic back pain, significantly impacting an individual's ability to function.
- Trial name
- NCT01028300
- Testing
- ProDisc™-L Total Disc Replacement (TDR)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Synthes USA HQ, Inc.
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive