Clinical trials: Spine Injury
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 Fractures, Vertebral Compression Fractures
Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus…
- Conditions
- Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Osteoporosis
- Trial name
- SAKOS (NCT02461810)
- Testing
- Vertebral fracture surgery SpineJack®, Balloon Kyphoplasty
- Where
- 13 sites in France, Germany and 3 more
- Volunteers
- 152 people
- Sponsor
- Vexim SA
Injury, Spinal Cord
Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care
This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates…
- Trial name
- INSPIRE 2 (NCT03762655)
- Testing
- Neuro-Spinal Scaffold
- Where
- 16 sites in United States
- Volunteers
- 20 people
- Sponsor
- InVivo Therapeutics
Degenerative Disc Disease, Spondylolisthesis
Quintex® Follow-up After One Year Minimum
Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis
- Trial name
- Quintex (NCT04489394)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Osteoporosis, Osteoporosis, Age-Related
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
- Conditions
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis
- Trial name
- NCT03512262
- Testing
- Abaloparatide
- Where
- 34 sites in United States, Italy and 1 more
- Volunteers
- 228 people
- Sponsor
- Radius Health, Inc.
Degenerative Disc Disease, Spondylolisthesis
PMCF Neo Pedicle Screw and Cage Systems
The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Tumor
- Trial name
- NCT03956537
- Testing
- NEO Pedicle Screw System™, Neo Cage System™
- Where
- 2 sites in Germany, Spain
- Volunteers
- 150 people
- Sponsor
- Neo Medical SA
Cervical Spinal Cord Injury, Spine Injury
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute…
- Conditions
- Cervical Spinal Cord Injury, Spine Injury, Spinal Cord Trauma
- Trial name
- NCT02302157
- Testing
- AST-OPC1
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lineage Cell Therapeutics, Inc.
Spine Degeneration, Spine Spondylosis Thoracic
Clariance ErYs Registry
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months…
- Conditions
- Spine Degeneration, Spine Spondylosis Thoracic, Spinal Deformity, Spinal Tumor
- Trial name
- ErYs (NCT05170815)
- Testing
- Spine surgery
- Where
- France
- Volunteers
- 760 people
- Sponsor
- Clariance
Degenerative Disc Disease, Kyphosis
Post-Market Clinical Follow-up Study of A-SPINE's Products
This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before…
- Conditions
- Degenerative Disc Disease, Kyphosis, Scoliosis, Trauma
- Trial name
- NCT04848376
- Testing
- (1) SmartLoc (2) SmartLoc Evo (3) Winloc(4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L
- Where
- Taiwan
- Volunteers
- 200 people
- Sponsor
- A-Spine Asia Co., Ltd.
Spinal Fractures
PASS MIS® Post-market Clinical Follow-up
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
- Trial name
- NCT02931266
- Testing
- PASS MIS®
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Medicrea International
Acute Traumatic Spinal Cord Injury
Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury
The main objective of the study is the evaluation of the safety and tolerability of FAB117-HC (a medicinal product containing human allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, HC016…
- Trial name
- SPINE (NCT02917291)
- Testing
- FAB117-HC, Control group
- Where
- 9 sites in Spain
- Volunteers
- 48 people
- Sponsor
- Ferrer Internacional S.A.
Spinal Cord Neoplasms, Spinal Fractures
The Development of a Vertebra Localizing Aid Medical Device
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made.
- Trial name
- NCT02603874
- Testing
- Target Tape
- Volunteers
- 100 people
- Sponsor
- Target Tape
Postmenopausal Osteoporosis
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
- Trial name
- VERO (NCT01709110)
- Testing
- Teriparatide, Risedronate, Calcium
- Where
- 103 sites in United States, Argentina and 13 more
- Volunteers
- 1,366 people
- Sponsor
- Eli Lilly and Company
Spinal Cord Injury, Erectile Dysfunction
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as…
- Conditions
- Spinal Cord Injury, Erectile Dysfunction, Spinal Cord Trauma, Injuries, Spinal Cord
- Trial name
- NCT00654082
- Testing
- sildenafil
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 88 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Dural Sealing
DuraSeal Exact Spine Sealant System Post-Approval Study
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
- Trial name
- DuraSeal PAS (NCT01410864)
- Testing
- DuraSeal Exact Spine Sealant System, Control
- Where
- 36 sites in United States
- Volunteers
- 924 people
- Sponsor
- Integra LifeSciences Corporation
Spinal Cord Compression
Validation of AI Lumbar Spine Anatomy Measureing Function
Spinal degeneration and its associated clinical diseases are common ailments in aging societies. With the advent of a super-aging society, the importance of assistive technologies for spinal image interpretation is increasingly…
- Trial name
- Spinal cord (NCT06950411)
- Where
- Taiwan
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- RadiRad Co., Ltd.
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Spinal Fractures
Study to Investigate the Long Term Survivorship of Coflex
Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.
- Trial name
- NCT02918669
- Testing
- CT Scan
- Volunteers
- 12 people
- Sponsor
- Paradigm Spine
Kyphosis, Spinal Fractures
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
- Trial name
- LOADPRO (NCT02768675)
- Testing
- LOADPRO
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Intellirod Spine
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