Clinical trials: Lumbar Degenerative Disc Disease
Intervertebral Disc Degeneration, Stenosis, Spinal
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk…
- Conditions
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity
- Trial name
- NCT05648474
- Testing
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Alphatec Spine, Inc.
Low Back Pain, Obesity
The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain
The purpose of the research study is to assess the impact of traction forces on changes in systemic markers concentrations of spinal structure damage in people with obesity.
- Trial name
- NCT04507074
- Testing
- lumbar traction therapy
- Where
- Poland
- Volunteers
- 49 people
- Sponsor
- Poznan University of Physical Education
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Fusion or Not - a Study on Low Back Pain
Problems from the musculoskeletal system are one of the most common reasons for disability and sick leave. These problems include low back pain. Low back pain affects as many as 8 out of 10 individuals at some point in life.
- Trial name
- NCT06709391
- Testing
- Fusion surgery, Non-fusion surgery
- Where
- 4 sites in Sweden
- Volunteers
- 90 people
- Sponsor
- Uppsala University
Disc Degeneration, Low Back Pain
Lumbar Spine Muscle Degeneration Inhibits Rehabilitation-Induced Muscle Recovery
Low back pain (LBP) is a complex condition that affects 65-85% of the population, and is the leading musculoskeletal condition contributing to disability in the United States.
- Trial name
- NCT03442374
- Testing
- Exercise
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of California, San Diego
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
Degenerative Disc Disease, Low Back Pain
Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
Modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. Modic type 1 change is considered an inflammatory process.
- Trial name
- NCT04930211
- Testing
- Dexamethasone-Lidocaine
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Marmara University
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
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
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.
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.
Spine Health, Spine Injuries and Disorders
Occupational Exposure to Whole Body Vibration Among U.S. Military Veterans: Acute and Chronic Contributions to Musculoskeletal Disorders and Spine-Area Pain
Significance to VA: There is a lack of prospective longitudinal studies investigating the relationship between risk factors to Veterans and development and progression of musculoskeletal (MSK) spine injury and pain.
- Conditions
- Spine Health, Spine Injuries and Disorders, Spine Degeneration, Whole Body Vibration
- Trial name
- NCT07367139
- Testing
- Water
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Milwaukee VA Medical Center
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
Lumbar Disc Herniation, Protrusion
Lumbar Kinematics in People With the Low Back Pain
This study evaluates the effect of lumbar disc herniation on kinematics in the lumbopelvic region during daily living activities.
- Conditions
- Lumbar Disc Herniation, Protrusion, Extrusion of Migrated Disc, Hernia
- Trial name
- NCT04417855
- Testing
- G-Walk
- Where
- Poland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Wroclaw University of Health and Sport Sciences
Degenerative Disc Disease Lumbar
A Study of LDGraft In Single Level Lumbar Interbody Fusion
The objective of the study is to evaluate the safety and effectiveness of LDGraft (investigational device) when applied in a lumbar interbody fusion procedure in the treatment of patients with lumbar Degenerative Disc Disease…
- Trial name
- AMBITION (NCT07858643)
- Testing
- LDGraft
- Where
- 2 sites in Georgia
- Volunteers
- 25 people
- Sponsor
- Locate Bio Ltd
Spondylolisthesis, Lumbar Region, Spinal Trauma With Neurological Deficit
Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime
The Viper Prime/Expedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or…
- Conditions
- Spondylolisthesis, Lumbar Region, Spinal Trauma With Neurological Deficit, Degeneration of Lumbar Intervertebral Disc
- Trial name
- NCT06704906
- Testing
- Use of Viper Prime/Expedium system with Fibergraft BG Putty
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Nitin Agarwal
Degenerative Disc Disease
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion
The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion. The secondary objective of this clinical trial is to assess clinical outcome measurements.
- Trial name
- APPRAISET1 (NCT01013389)
- Testing
- Actifuse ABX, INFUSE, plus master granules (MGG)
- Where
- 2 sites in Australia, Netherlands
- Volunteers
- 20 people
- Sponsor
- Baxter Healthcare Corporation
Low Back Pain, Spondylolisthesis
Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain
Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis.
- Conditions
- Low Back Pain, Spondylolisthesis, Spondylosis, Spinal Instability
- Trial name
- NCT01918943
- Testing
- PLIF and Aspen (spinous process fixation device)
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- American British Cowdray Medical Center
Degenerative Disc Disease Lumbar, Spinal Stenosis
Multimodal Analgesia Versus Routine Care Pain Management
Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization.
- Conditions
- Degenerative Disc Disease Lumbar, Spinal Stenosis, Lumbar Spondylolisthesis
- Trial name
- MMA (NCT01861743)
- Testing
- Multimodal Analgesia, Patient controlled analgesia
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
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
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.