Clinical trials: Vertebral 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.
Intervertebral Disc Disease, Spondylolisthesis
PASS OCT® Post-market Clinical Follow-up
Prospective, multicenter non comparative and observational study (post-market clinical follow-up). Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
- Conditions
- Intervertebral Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Neoplasms
- Trial name
- NCT02931279
- Testing
- PASS OCT® Spinal System
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Medicrea International
Osteoporosis, Postmenopausal, Back Pain
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.
- Conditions
- Osteoporosis, Postmenopausal, Back Pain, Spinal Fracture
- Trial name
- NCT00343252
- Testing
- teriparatide, risedronate
- Where
- 72 sites in United States, Argentina and 11 more
- Volunteers
- 712 people
- Sponsor
- Eli Lilly and Company
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
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.
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.
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
Osteoporosis
Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.
- Trial name
- ACTIVATE (NCT00616694)
- Testing
- Actonel
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- Sanofi
Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Spinal Stenosis, Scoliosis
- Trial name
- NCT06532968
- Testing
- ORION spinal lamina cover
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Orion Biotech 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
Back Pain
The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)
The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).
- Trial name
- NCT00713258
- Testing
- Parathyroid hormone (PTH) (1-84), Alendronate
- Where
- Denmark
- Volunteers
- 75 people
- Sponsor
- Nycomed
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
Osteoporosis
Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)
Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected to be effective in preventing fractures in osteoporotic women.
- Trial name
- LIFT (NCT00519857)
- Testing
- Tibolone
- Volunteers
- 4,534 people
- Sponsor
- Organon and Co
Spinal Fractures
Study to Investigate the Long Term Survivorship of Coflex
Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.
- Trial name
- NCT02918669
- Testing
- CT Scan
- Volunteers
- 12 people
- Sponsor
- Paradigm Spine
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
Primary Osteoporosis
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis
To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day.
- Trial name
- NCT00447915
- Testing
- ibandronic acid 0.5mg, 1.0mg ibandronic acid, 2.5mg RIS
- Where
- 4 sites in Japan
- Volunteers
- 1,265 people
- Sponsor
- Chugai Pharmaceutical
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