Clinical trials: Spinal Surgery
Spinal Anesthesia, Vascular Surgery
Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery
This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.
- Trial name
- NCT03883763
- Testing
- bupivacaine S75:R25 plus 8% glucose, bupivacaine S50:R50 plus 8% glucose
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Failed Back Surgery Syndrome, Back Pain
Spinal Cord Stimulation for Predominant Low Back Pain
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering…
- Conditions
- Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
- Trial name
- PROMISE (NCT01697358)
- Testing
- Spinal Cord Stimulation (SCS), Optimal Medical Management (OMM)
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 278 people
- Sponsor
- MedtronicNeuro
Chronic Back Pain
SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
- Trial name
- NOVA (NCT04571242)
- Testing
- DTM Programming, Conventional SCS programming
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- SGX Nova LLC
Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal Cord, CT Scans
Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test
CT scans of the spine include vertebrae, intervertebral discs and the spinal cord. These tests are performed in an orderly protocol and allow for three-dimensional reconstruction of the vertebra in sagittal and coronal guides.
- Trial name
- NCT04914585
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Deep Health Ltd.
Herniation, Disc
Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied.
- Trial name
- NCT06369233
- Testing
- MegaShield®-SP, Guardix-SP Plus
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- L&C Bio
Chronic Pain, Pain, Intractable
An Implantable Spinal Cord Stimulation Pain Management System
There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous…
- Conditions
- Chronic Pain, Pain, Intractable, Pain, Back Pain
- Trial name
- NCT00205855
- Testing
- Precision SCS
- Where
- 9 sites in United States
- Volunteers
- 65 people
- Sponsor
- Boston Scientific Corporation
Degenerative Spondylolisthesis, Spinal Stenosis
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral…
- Trial name
- ENHANCE (NCT04483297)
- Testing
- AK1320 MS, Control
- Where
- 7 sites in Canada
- Volunteers
- 30 people
- Sponsor
- Asahi Kasei Therapeutics Corporation
Spinal Dural Defect, Cerebrospinal Fluid Leakage
Dural Medical Adhesive for Watertight Sealing in Dural Repair
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage.
- Conditions
- Spinal Dural Defect, Cerebrospinal Fluid Leakage, Spinal Neurosurgery
- Trial name
- NCT07754344
- Testing
- Dural medical adhesive, Standard dural reinforcement surgery
- Where
- 6 sites in China
- Volunteers
- 141 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Spinal Injuries, Adhesions
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group…
- Trial name
- NCT00387829
- Testing
- DuraGen Plus Adhesion Barrier Matrix
- Where
- 36 sites in United States
- Volunteers
- 347 people
- Sponsor
- Integra LifeSciences Corporation
Lumbar Spine Stenosis, Lumbar Spine Degeneration
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research.
- Trial name
- NCT05452694
- Where
- 3 sites in United States
- Volunteers
- 235 people
- Sponsor
- OpalGenix, Inc
Spinal Cord Injury
A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: those with a complete cervical injury or a…
- Trial name
- NCT00500812
- Testing
- Cethrin
- Where
- 8 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Lumbar Spinal Stenosis
The Vertos MILD™ Preliminary Patient Evaluation Study
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for…
- Trial name
- NCT00749073
- Testing
- Minimally Invasive Lumbar Decompression (MILD™)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Vertos Medical, Inc.
Lumbar Spinal Stenosis, Spondylolisthesis
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple…
- Trial name
- SPSI (NCT03754972)
- Testing
- Sagittal plane shear index (SPSI)
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Medical Metrics Diagnostics, Inc
Scoliosis
Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis
To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients
- Trial name
- PEDSCOLI (NCT02084264)
- Where
- 4 sites in United States
- Volunteers
- 272 people
- Sponsor
- Mazor Robotics
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
Vertebral Fracture, Compression Fracture
Spine Bone Cements Outcomes - Post Market Follow-up
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all…
- Conditions
- Vertebral Fracture, Compression Fracture, Osteoporotic Fractures
- Trial name
- NCT06367582
- Testing
- Vertebroplasty (VP), Kyphoplasty (KP), Pedicular Screw Augmentation (PSA)
- Where
- 12 sites in France, Portugal and 2 more
- Volunteers
- 500 people
- Sponsor
- Teknimed
Symptomatic Cervical Disc Disease
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease…
- Trial name
- SMART (NCT04012996)
- Testing
- prodisc C SK and/or Vivo, Mobi-C Cervical Disc
- Where
- 30 sites in United States
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Centinel Spine
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Spinal Fusion, Deformity of Spine
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
- Trial name
- PAULA (NCT05640908)
- Testing
- iFuse Bedrock Granite Implant System
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- SI-BONE, Inc.
Spinal Diseases
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
- Trial name
- NCT03015142
- Testing
- New image-guidance software
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Philips Clinical & Medical Affairs Global