Clinical trials: Vertebral Compression Fracture
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.
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.
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
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.
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
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
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
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
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
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 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.
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
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, 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
Osteoporosis, Postmenopausal
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be…
- Trial name
- TOP (NCT01381588)
- Testing
- Fracture evaluation
- Where
- South Korea
- Volunteers
- 1,136 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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 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 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
Osteopenia, Osteoporosis
FREE Study - Fracture Reduction Evaluation
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.
- Conditions
- Osteopenia, Osteoporosis, Multiple Myeloma, Bone Neoplasms
- Trial name
- NCT00211211
- Testing
- Balloon Kyphoplasty
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Spine LLC