Clinical trials: Vertebral Compression Fractures
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
Spinal Fractures, Fractures, Compression
The Kiva® System as a Vertebral Augmentation Treatment
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or…
- Conditions
- Spinal Fractures, Fractures, Compression, Back Injuries
- Trial name
- KAST (NCT01123512)
- Testing
- Vertebral augmentation
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Benvenue Medical, Inc.
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
Vertebral Body Fractures
Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting
This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine.
- Trial name
- NCT01847898
- Testing
- Vertebral Body Stenting (VBS), Balloon Kyphoplasty
- Where
- 5 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- Synthes GmbH
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
Pathologic Fracture of the Vertebra Due to Osteoporosis
Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients
The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
- Trial name
- NCT00933036
- Testing
- Crosstrees Pod system for PVA
- Where
- 9 sites in United States
- Volunteers
- 135 people
- Sponsor
- Crosstrees Medical Inc.
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
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
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
Back Pain
Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF)…
- Trial name
- NCT00771758
- Testing
- oxycodone IR, tapentadol IR
- Where
- 37 sites in United States
- Volunteers
- 108 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, 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
Multiple Myeloma, Compression Fracture of Vertebral Column
Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma
The objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.
- Trial name
- MM (NCT01410929)
- Testing
- Kyphoplasty/Vertebral Augmentation (Device-StabiliT)
- Sponsor
- DFINE Inc.
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.
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
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
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
Painful Osteoporotic Vertebral Compression Fractures (VCF)
The PRIORi-T Trial--Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation
The objective of this post market clinical investigation is to evaluate the clinical effectiveness of a minimally invasive vertebral augmentation procedure, Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to…
- Trial name
- PRIORi-T (NCT01480167)
- Testing
- Vertebral Augmentation (STABILIT), Non-operative Management
- Where
- 6 sites in United States
- Sponsor
- DFINE Inc.
Vertebra Compression Fracture, Osteoporotic Fractures
Post-market Observational Clinical Study With the Medical Device 'SPHEREPLAST'
This is a retrospective, single-centre, single-arm post-market observational study evaluating the safety and clinical performance of the SPHEREPLAST medical device used in balloon kyphoplasty procedures for the treatment of…
- Trial name
- NCT07242677
- Where
- Italy
- Volunteers
- 37 people
- Sponsor
- MT Ortho s.r.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
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