Clinical trials: Spine Injuries and Disorders
Scoliosis, Scoliosis; Adolescence
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question[s]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS)…
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region
- Trial name
- PKSforPSP (NCT06554093)
- Testing
- Medical Device - PKS
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Deep Health Ltd.
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.
Fusion of Spine (Disease), Fractures, Ununited
A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.
- Trial name
- NCT01750840
- Testing
- Biomet® EBI Bone Healing System, Biomet Orthopak® Non-Invasive Bone Growth Stimulator System, Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Zimmer Biomet
Spinal Fractures
A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis
Doctors are studying an investigational treatment to be used during the vertebroplasty procedure when treating vertebral compression fractures (spine fractures) that may help to reduce pain and restore mobility.
- Trial name
- NCT00290862
- Testing
- Percutaneous Vertebral Augmentation of compression fractures
- Where
- 18 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- Orthovita d/b/a Stryker
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.
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
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 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
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
Spondylolisthesis, Neurologic Deficits
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
The purpose of the Post-Market Surveillance study is to evaluate safety.
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Trial name
- DSS (NCT01461005)
- Testing
- Dynamic Stabilization System (DSS)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Paradigm Spine
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
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.
Osteoporosis, Postmenopausal, Osteoporosis
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporosis Vertebral, Osteoporosis Risk
- Trial name
- NCT03710889
- Testing
- Abaloparatide
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Radius Health, Inc.
Degenerative Disc Disease, Craniocervical Injuries
Posterior Cervical Fixation Study
The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported…
- Conditions
- Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease
- Trial name
- NCT04770571
- Testing
- observational study
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- NuVasive
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
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.
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.
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