Clinical trials: Kyphoplasty
Metastatic Lesions in Vertebral Bodies
Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors
To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.
- Trial name
- EU-STAR (NCT02081053)
- Testing
- STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- DFINE Inc.
Osteoporotic Vertebral Fracture, Between T5 and L5
Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures
This study aims to compare two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the following: 1.
- Conditions
- Osteoporotic Vertebral Fracture, Between T5 and L5, Chronic Arthritis, Longer Than Six Weeks Duration
- Trial name
- OSTEO+6 (NCT00749086)
- Testing
- balloon kyphoplasty, vertebroplasty
- Where
- France
- Volunteers
- 97 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Osteoporotic Vertebral Fracture, Between T5 and L5
Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures
This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.
- Conditions
- Osteoporotic Vertebral Fracture, Between T5 and L5, of Less Than 6 Weeks Duration
- Trial name
- OSTEO-6 (NCT00749060)
- Testing
- conventional treatment, kyphoplasty with balloons, vertebroplasty
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cancer, Metastasis
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like…
- Conditions
- Cancer, Metastasis, Pain
- Trial name
- NCT00374751
- Testing
- Samarium (153SM)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- New York Presbyterian Brooklyn Methodist Hospital
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, Vertebra Compression Fracture
Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management
The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.
- Conditions
- Vertebral Compression, Vertebra Compression Fracture, Vertebral Fracture
- Trial name
- NCT04774029
- Testing
- Basivertebral nerve block, Lidocaine induced basivertebral nerve block
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Northwell Health
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 Fracture
Kyphoplasty With Structured Titanium Spheres
The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).
- Trial name
- NCT04169659
- Testing
- Kyphoplasty with insertion of Sctructured Titanium Microspheres, Kyphoplasty with Polimethylmetacrilate (convetional surgery)
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- ARNAS Civico Di Cristina Benfratelli Hospital
Spine Fracture
Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures
Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height…
- Trial name
- NCT03850938
- Testing
- Conventional Kyphoplasty, Kyphoplasty with Rotary Cutter
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Li Min
Metastatic Lesions in Vertebral Bodies
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following…
- Trial name
- STARRT (NCT02225223)
- Testing
- STAR™ Tumor Ablation System, StabiliT® Vertebral Augmentation System
- Where
- 14 sites in United States
- Volunteers
- 35 people
- Sponsor
- Merit Medical Systems, Inc.
Vertebral Compression Fracture
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body…
- Trial name
- NCT01383616
- Testing
- Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Hospital for Special Surgery, New York
Osteoporosis, Osteoporotic Vertebral Compression Fractures
Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System
Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients.
- Trial name
- CMT-VX (NCT07665424)
- Testing
- CMT Vessel-X® Bone Filling Container System, CMT Manual Orthopedic Surgical Instruments
- Where
- 2 sites in Taiwan
- Volunteers
- 146 people
- Sponsor
- Juin-Hong Cherng
Vertebral Compression Fracture
Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement
The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone…
- Trial name
- NCT04581707
- Testing
- Kyphoplasty Single Balloon Catheter Allevo, Quattroplasty Double Balloon Catheter Stop'n GO
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- University Hospital Tuebingen
Orthopedic Disorder of Spine
PKP Assisted With MR Technology in OVCF With IVC
To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.
- Trial name
- NCT03959059
- Testing
- Mixed Reality technology
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Osteoporotic Fracture of Vertebra
Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Body Fractures.
Vertebral body fractures are a major health care problem in all countries with incidence 1.4%. They are a common cause of severe debilitating pain, with consequent deteriorated quality of life, physical function and psychosocial…
- Trial name
- NCT03682328
- Testing
- vertebroplasty, kyphoplaty
- Volunteers
- 23 people
- Sponsor
- Assiut University
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.