Clinical trials: Vertebral Compression
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
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
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 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
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
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
Degenerative Disc Disease
rhBMP-2/CRM/CD HORIZON® Spinal System Pilot Study (2-Level)
The purpose of this study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent…
- Trial name
- NCT01491568
- Testing
- rhBMP-2/CRM/CD HORIZON® Spinal System
- Volunteers
- 29 people
- Sponsor
- Medtronic Spinal and Biologics
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
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
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, 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
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
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
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
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
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