Clinical trials: Degenerative Lumbar Diseases
Degenerative Disc Disease
Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion
The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.
- Trial name
- NCT05972616
- Testing
- Natural Matrix Protein (NMP)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Induce Biologics USA Inc.
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, 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
Degenerative Lumbar Spinal Stenosis
Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Post-operative Functional Incapacity (BDYNCLIN)
Degenerative Lumbar Spinal Stenosis (LSS) is an extremely common condition affecting more than 102 million people each year. It is a narrowing of the spinal canal in the lower back.
- Trial name
- BDYNCLIN (NCT04407338)
- Testing
- B-DYN, Conventional Bolted fusion (with or without cage)
- Where
- 2 sites in France
- Volunteers
- 216 people
- Sponsor
- Quanta Medical
Disc Degeneration of Pfirrmann Grade III or Greater, Degenerative Spondylolisthesis
Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial
This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant.
- Conditions
- Disc Degeneration of Pfirrmann Grade III or Greater, Degenerative Spondylolisthesis, Isthmic Spondylolisthesis of Grade I or II
- Trial name
- SNAP (NCT01557829)
- Testing
- Posterior lumbar interbody fusion with a PEEK cage, Posterior lumbar interbody fusion with a Valeo OL cage
- Where
- 2 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Amedica Corporation
Spinal Stenosis
Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar…
- Trial name
- NCT01316211
- Testing
- Implantation of coflex™ after surgical decompression, Surgical decompression
- Where
- 8 sites in Germany
- Volunteers
- 246 people
- Sponsor
- Paradigm Spine
Degenerative Disc Disease, Spondylolisthesis
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion.
- Trial name
- NCT03810573
- Testing
- NB1
- Where
- 2 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Bone Biologics Corp
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
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
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.
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 Disc Disease, Disc Degeneration
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
VIA Disc NP is an off-the-shelf minimally processed human nucleus pulposus tissue allograft intended to supplement degenerated intervertebral discs.
- Conditions
- Degenerative Disc Disease, Disc Degeneration, Lumbar Discogenic Pain
- Trial name
- ASCEND (NCT06615505)
- Testing
- VIA Disc NP
- Where
- 5 sites in Australia
- Volunteers
- 121 people
- Sponsor
- VIVEX Biologics, Inc.
Degenerative Disc Disease, Spondylolisthesis
Retrospective Modulus ALIF Study
The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Stenosis
- Trial name
- NCT05566704
- Testing
- Modulus ALIF System
- Where
- 5 sites in United States
- Volunteers
- 123 people
- Sponsor
- NuVasive
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
NanoFUSE® PL Gutter PMCF
This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.
- Trial name
- NCT03751943
- Testing
- NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)
- Volunteers
- 50 people
- Sponsor
- NanoFUSE Biologics, LLC
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
A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease
This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration.
- Trial name
- IDCT (NCT07254806)
- Testing
- IDCT (rebonuputemcel)
- Where
- 31 sites in United States
- Volunteers
- 162 people
- Sponsor
- DiscGenics, Inc.
Intervertebral Disc Degeneration
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal…
- Trial name
- TLIF (NCT05997121)
- Testing
- Transforaminal lumbar interbody fusion
- Where
- 6 sites in France, Switzerland
- Volunteers
- 187 people
- Sponsor
- SPINEVISION SAS
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
Virtuos Bone Graft in Lumbar Fusion
A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels
- Trial name
- NCT06686017
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Orthofix Inc.