Clinical trials: Spine Injury
Spinal Deformity, Spinal Degenerative Disorder
The Ailliance Post-Market Clinical Study
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months.
- Conditions
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma
- Trial name
- NCT05856370
- Testing
- Follow-up schedule: pre-operative baseline up to 24-months post-procedure
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Spinal and Biologics
Spine Injuries and Disorders, Pain, Chronic
Real-Time Accurate Pathology Inspection and Decompression Study
The primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (LAND) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain.
- Conditions
- Spine Injuries and Disorders, Pain, Chronic, Pain, Back, Pain, Neck
- Trial name
- RAPID (NCT05347108)
- Testing
- laser-assisted neural decompression (LAND) procedure
- Where
- United States
- Sponsor
- KM Clinical Research Group
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 Disorders/Injuries
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
This protocol is designed to study Orthofix regulatory approved and commercially available spine devices to generate Real World Evidence (RWE) of device safety and performance in the treatment of patients with spine injuries…
- Trial name
- RWE Spine (NCT05082090)
- Testing
- Spinal Surgery
- Where
- 20 sites in United States, Germany and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Orthofix 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
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.
Degenerative Disc Disease (DDD), Instabilities
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Trial name
- NCT05489822
- Testing
- VERTICALE® Cervical System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Silony Medical GmbH
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
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.
Cervical Spinal Cord Injury, Spine Injury
Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
- Conditions
- Cervical Spinal Cord Injury, Spine Injury, Cervical Spine Injury
- Trial name
- NCT02163876
- Testing
- HuCNS-SC cells
- Where
- 14 sites in United States, Canada
- Volunteers
- 31 people
- Sponsor
- StemCells, Inc.
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.
Spine Fracture, Degenerative Disc Disease
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications
- Conditions
- Spine Fracture, Degenerative Disc Disease, Spinal Instability, Spinal Tumor
- Trial name
- CERISE (NCT05296889)
- Testing
- posterior stabilization for the cervical spine
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Cancer, Spinal Fractures
CAFE Study - Cancer Patient Fracture Evaluation
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients…
- Trial name
- CAFE (NCT00211237)
- Testing
- Balloon Kyphoplasty, Non Surgical Management
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 134 people
- Sponsor
- Medtronic Spine LLC
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.
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
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.
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
Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Spinal Stenosis, Scoliosis
- Trial name
- NCT06532968
- Testing
- ORION spinal lamina cover
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Orion Biotech Inc.
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
Male Osteoporosis
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.
- Trial name
- NCT00439647
- Testing
- Zoledronic acid 5 mg iv
- Where
- 128 sites in Argentina, Australia and 21 more
- Volunteers
- 1,199 people
- Sponsor
- Novartis Pharmaceuticals