Clinical trials: Lumbar Disc Disease
Degeneration of Lumbar Intervertebral Disc
OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
The purpose of this study was to collect data to demonstrate the safety and effectiveness of the OptiMesh 1500S to contain and reinforce bone graft materials in patients with Degenerative Disc Disease (DDD) whose condition…
- Trial name
- OLIF (NCT00764491)
- Testing
- Structural Allograft Spacer, OptiMesh 1500S
- Where
- 11 sites in United States
- Volunteers
- 156 people
- Sponsor
- Spineology, Inc
Cervical Disc Disorder With Radiculopathy, Spinal Stenosis
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion…
- Conditions
- Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified
- Trial name
- NCT06365307
- Testing
- Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), Synthetic osteoplastic material based on β-TCP or bone autograft
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Histograft Co., Ltd.
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
AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain
This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted single injection of AMG0103 in subject with chronic discogenic lumbar back pain
- Trial name
- NCT03263611
- Testing
- AMG0103
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- AnGes, Inc.
Stenosis, Spondylolisthesis
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae)…
- Conditions
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT00254852
- Testing
- Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF)
- Where
- 6 sites in United States
- Volunteers
- 94 people
- Sponsor
- Exactech
Degenerative Disc Disease, Spondylolisthesis, Grade 1
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
- Trial name
- APROPOS (NCT02704689)
- Testing
- AccuLIF expandable TLIF cage
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- VB Spine, LLC
Lumbar Degenerative Disc Disease
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease.
- Trial name
- MODEL (NCT05516992)
- Testing
- SB-01 For Injection
- Where
- 30 sites in United States
- Volunteers
- 417 people
- Sponsor
- Spine BioPharma, Inc
Degenerative Disc Disease
A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion
The primary objective of the study is to assess the overall efficacy of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion.
- Trial name
- NCT06115512
- Testing
- AGA111
- Where
- 35 sites in China
- Volunteers
- 412 people
- Sponsor
- Angitia Biopharmaceuticals
Lumbar Disc Herniation
PMCFU of an Annular Closure System
The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.
- Trial name
- NCT05467072
- Testing
- Annular closure
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Intrinsic Therapeutics
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
Spinal Lumbar Stenosis, Claudication, Intermittent
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
- Trial name
- LB2CT01 (NCT05587465)
- Testing
- Lobster Device
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Diametros Medical srl
Lumbar Herniated Intervertebral Disc
The Efficacy and Safety of the 1,414 nm Nd:YAG Laser System for Alleviating Back Pain in a Lumbar Disc Patient
This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to alleviate back pain in a lumbar herniated…
- Trial name
- NCT02598232
- Testing
- 1,414nm Nd:YAG Laser System
- Volunteers
- 30 people
- Sponsor
- CynosureLutronic
Degenerative Disc Disease
Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease
The goal of this clinical trial is to estimate the cumulative reoperation rate at upper adjacent segment level in patients treated with BDyn dynamix stabilization for lumbar degenerative disc diseases over long-term follow-up.
- Trial name
- MOBIDYN (NCT07580664)
- Testing
- Dynamic Lumbar Stabilization Device
- Volunteers
- 150 people
- Sponsor
- Cousin Biotech
Degenerative Disc Disease, Spinal Fusion
KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
The purpose of this study is to evaluate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) compared to local autograft for the treatment of Degenerative Disk Disease (DDD).
- Trial name
- STRUCTURE (NCT04294004)
- Testing
- TGplPTH1-34 in fibrin, Autologous Bone Graft
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- Kuros Biosurgery AG
Degenerative Disc Disease
Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of…
- Trial name
- TLF (NCT00965380)
- Where
- 15 sites in United States
- Volunteers
- 207 people
- Sponsor
- Orthofix Inc.
Intervertebral Disc Disease, Lumbar Disc Disease
A Study of SI-6603 in Patients With Lumbar Disc Herniation
The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.
- Trial name
- NCT01941563
- Testing
- Condoliase
- Where
- 32 sites in United States
- Volunteers
- 385 people
- Sponsor
- Seikagaku Corporation
Lumbar Disc Herniation
Compare the Effects of Decompression on Lumber Disc Protrusion Patient
This is an RCT study in which 60 participant are included and half of the participant are randomized via lottery method in control and experimental group after fulfilling the inclusion criteria.
- Trial name
- NCT04860609
- Testing
- Conventional Physiotherapy, Lumber Spinal Decompression
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Aqua Medical Services (Pvt) Ltd
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
Lumbar Disc Herniation Surgery, Disc Herniation
Return to Activity After Surgery for Lumbar Disc Herniation
RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.
- Trial name
- NCT07667348
- Testing
- Postoperative therapy
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Intrinsic Therapeutics
Degenerative Disc Disease, Spondylolisthesis
MLX/XLX ACR Expandable Lumbar Interbody Implants
The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04420143
- Where
- 4 sites in United States
- Volunteers
- 109 people
- Sponsor
- NuVasive