Clinical trials: Vertebral Fractures
Vertebral Compression Fracture
A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults.
- Trial name
- EXPAND (NCT07301749)
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 3 sites in France, Germany
- Volunteers
- 148 people
- Sponsor
- Amber Implants B.V.
Vertebral Compression Fracture
Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration
This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and…
- Trial name
- NCT07259811
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 2 sites in Germany
- Volunteers
- 10 people
- Sponsor
- Amber Implants B.V.
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.
Vertebral Compression Fracture, Vertebral Compression
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.
- Conditions
- Vertebral Compression Fracture, Vertebral Compression, Vertebral Fracture
- Trial name
- NCT04821739
- Testing
- AGN1 LOEP SV Kit
- Where
- 3 sites in Germany, Spain
- Volunteers
- 100 people
- Sponsor
- AgNovos Healthcare, LLC
Vertebral Compression Fracture, Compression Fracture
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs).
- Conditions
- Vertebral Compression Fracture, Compression Fracture, Vertebral Compression
- Trial name
- NCT04835428
- Testing
- Treatment Group: AGN1 LOEP SV Kit, Control Group: PMMA bone cement
- Where
- 12 sites in United States
- Volunteers
- 408 people
- Sponsor
- AgNovos Healthcare, LLC
Kyphoplasty, Vertebroplasty
A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants
The primary objective of this observational study is to evaluate fracture stability through longitudinal assessment of subject-reported pain following treatment with the OsteoPearl Biological Allograft in men and women aged ≥50…
- Conditions
- Kyphoplasty, Vertebroplasty, Vertebral Compression Fracture, Allograft
- Trial name
- PEARL ONE (NCT07561489)
- Testing
- Allograft
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Lenoss Medical
Vertebral Compression Fracture
Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures
The overall purpose of conducting this study is to evaluate the safety and efficacy of V-Flex and V-Steady for augmentation of osteoporotic vertebral compression fractures and to verify that adding a cement softener into a PMMA…
- Trial name
- SOFTBONE (NCT05676320)
- Testing
- V-Flex, V-Steady
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 203 people
- Sponsor
- Inossia AB
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
Osteoporotic Vertebral Compression Fractures
Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures
The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.
- Trial name
- NCT06270173
- Testing
- Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)
- Where
- 4 sites in Germany
- Volunteers
- 53 people
- Sponsor
- Wiltrom Co., Ltd.
Osteoporotic Vertebral Compression Fractures
SpineJack System Postmarket Registry
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
- Trial name
- NCT04795765
- Testing
- SpineJack system, Balloon kyphoplasty, Vertebroplasty
- Where
- 12 sites in United States
- Volunteers
- 261 people
- Sponsor
- Stryker Instruments
SPINAL Fracture, Vertebral Fractures
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients…
- Conditions
- SPINAL Fracture, Vertebral Fractures, Spinal Stenosis, Kyphosis
- Trial name
- NCT06153511
- Testing
- Robot assisted spinal transpedicular fixation
- Where
- Spain
- Volunteers
- 13 people
- Sponsor
- Cyber Surgery S.L.
Spinal Fractures, Vertebral Compression Fractures
SpineJack® Versus Conservative Treatment Study (SPICO Study)
This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows: 1. SpineJack® system 2.
- Conditions
- Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Trauma
- Trial name
- NCT02657265
- Testing
- SpineJack system, Conservative management
- Where
- 9 sites in France
- Volunteers
- 100 people
- Sponsor
- Vexim SA
Vertebral Compression Fracture
The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System
The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.
- Trial name
- NCT03580434
- Testing
- V-STRUT
- Where
- 3 sites in France
- Volunteers
- 9 people
- Sponsor
- Hyprevention
Vertebral Compression Fractures
OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA)…
- Trial name
- OsseoFix (NCT00961714)
- Testing
- OsseoFix Spinal Fracture Reduction System
- Where
- 11 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Alphatec Spine, Inc.
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.
Vertebral Body Compression Fracture(s)
Biological Allograft Chain Tissue Implant
A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.
- Trial name
- NCT04064710
- Testing
- Vertebral Body Augmentation, Manual Surgical Instruments
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Lenoss Medical
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
Vertebral Body Compression Fractures
KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures
Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty or vertebroplasty.
- Trial name
- NCT00323609
- Testing
- Vertebroplasty, Kyphoplasty
- Where
- 26 sites in United States, Canada
- Volunteers
- 404 people
- Sponsor
- Medtronic Spine LLC
Vertebral Body Compression Fractures (VCFs)
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a…
- Trial name
- MDTSCORE (NCT00810043)
- Testing
- Kyphon® Curette
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Spine LLC
Compression Fracture of Vertebral Body, Osteoporosis
Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs
The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of…
- Conditions
- Compression Fracture of Vertebral Body, Osteoporosis, Cancer
- Trial name
- EVOLVE (NCT01871519)
- Testing
- Balloon kyphoplasty
- Where
- 25 sites in United States
- Volunteers
- 354 people
- Sponsor
- Medtronic Spinal and Biologics