Clinical trials: Kyphoplasty
Spinal Fractures, Anesthesia, Regional
Effectiveness of Erector Spinae Block in Kyphoplasty
As of October 2019, when the investigators received the approval of the ethics committee, patients who were decided to undergo kyphoplasty with vertebral compression fracture will be included in the study.
- Conditions
- Spinal Fractures, Anesthesia, Regional, Anesthetics, Local, Analgesia
- Trial name
- NCT04201678
- Testing
- CLIA Group (conventional local anesthesia infiltration), EPIAA Group (Extrapedicular infiltration anesthesia), ESP Group (Erector Spina Block)
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Gulhane School of Medicine
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
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.
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.
Osteoporotic Vertebral Compression Fractures, Lung Function
Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation
Patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function.
- Trial name
- NCT01609712
- Testing
- Radiofrequency Kyphoplasty
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University Hospital, Bonn
Vertebral Body Compression Fractures
Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures
The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty.
- Trial name
- NCT01402167
- Testing
- Kyphoplasty, Vertebroplasty
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Metastatic Cancers, Multiple Myeloma
Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer
Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.
- Conditions
- Metastatic Cancers, Multiple Myeloma, Vertebral Fracture
- Trial name
- NCT02376933
- Testing
- Vertebroplasty, Radiotherapy
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Arizona
Erector Spinae Plane Block
Effect of Erector Spinae Plane Block in Patients Scheduled for Kyphoplasty
Patients, older than 50 years, with vertebral fracture scheduled for percutaneous balloon kyphoplasty will be enrolled for the study. Some patients will be under local anesthesia with sedation and analgesia for the procedure.
- Trial name
- NCT05970380
- Testing
- Erector spinae plane block, Local anesthesia
- Where
- Turkey (Türkiye)
- Volunteers
- 61 people
- Sponsor
- Bozyaka Training and Research Hospital
Vertebral Fracture, Kyphoplasty
Porous Titanium Microspheres in Kyphoplasty
Study is a prospective observational, performed in the context of normal clinical practice, of patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular…
- Trial name
- NCT05815251
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Unit of neurosurgery, Departement of Neurosciences, University of Torino
BKP, Osteoporotic Vertebral Compression Fracture
Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease
This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients…
- Conditions
- BKP, Osteoporotic Vertebral Compression Fracture, Kummell's Disease, Stent-screw-assisted Internal Fixation
- Trial name
- NCT06093087
- Testing
- SAIF, BKP
- Volunteers
- 70 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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
One or Two Traumatic Vertebral Fractures, Located Between T11 and L5
Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation
Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement.
- Conditions
- One or Two Traumatic Vertebral Fractures, Located Between T11 and L5, Balloon Kyphoplasty
- Trial name
- TRAUMAA3B1C1 (NCT00749229)
- Testing
- balloon kyphoplasty
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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.
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
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
Tumors
Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases
Vertebral column is the most prevalent location of bone metastases. Besides axial pain, vertebral metastases cause pathological fracture and neurological dysfunction by spinal cord compression.
- Trial name
- Kypho-IORT (NCT01280032)
- Testing
- intraoperative radiotherapy
- Where
- Germany
- Volunteers
- 18 people
- Sponsor
- Universitätsmedizin Mannheim
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
Spinal Metastases
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or potentially unstable spinal cord metastases.
- Trial name
- Kypho-IORT (NCT02987153)
- Testing
- Kypho-IORT
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Northwell Health
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.
Solid Tumors, Spine Metastasis
A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases
Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.
- Trial name
- KYPHO-01 (NCT02700308)
- Testing
- Kyphoplasty, Conventional vertebroplasty
- Where
- 2 sites in France
- Volunteers
- 31 people
- Sponsor
- Centre Leon Berard