Clinical trials: SPINAL 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.
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
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
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.
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
Pseudoarthrosis, Spinal Stenosis
A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an…
- Conditions
- Pseudoarthrosis, Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)
- Trial name
- NCT01972256
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Baxano Surgical, Inc.
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
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
Cuff Tear Arthropathy, Primary Osteoarthritis
Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis
This observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the Permedica's MIRAI Modular Shoulder Prosthesis System on the general population of patients who are…
- Conditions
- Cuff Tear Arthropathy, Primary Osteoarthritis, Secondary Osteoarthritis, Shoulder Osteoarthritis
- Trial name
- NCT05128500
- Testing
- Total Shoulder Arthroplasty with Permedica's MIRAI
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 76 people
- Sponsor
- Permedica spa
Spondylolisthesis, Neurologic Deficits
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
The purpose of the Post-Market Surveillance study is to evaluate safety.
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Trial name
- DSS (NCT01461005)
- Testing
- Dynamic Stabilization System (DSS)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Paradigm Spine
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
Healthy, Osteopenia
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-preFX (NCT06567054)
- Testing
- Measurements with the POROUS R3C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine, DXA-based Vertebral Fracture Assessment (VFA)
- Where
- 6 sites in Austria, Germany and 1 more
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH