Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System (CMT-VX)
The Clinical Investigation to Evaluate the Safety and Efficacy of 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. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns.
The Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief.
This post-market clinical study evaluates the safety and clinical effectiveness of the Vessel-X® Bone Filling Container System at two medical centers in Taiwan with a total target enrollment of 146 subjects:
Tri-Service General Hospital (TSGH): 86 subjects randomized in a 1:1 ratio to the experimental and control groups.
Taoyuan General Hospital, Ministry of Health and Welfare (TYGH): 60 subjects randomized in a 1:1 ratio to the experimental and control groups.
The primary objective is to evaluate the safety of the device by assessing the incidence of unanticipated serious adverse device effects (USADEs). Secondary objectives include evaluation of pain reduction measured by the Visual Analogue Scale (VAS), functional recovery assessed by the Oswestry Disability Index (ODI), and radiographic outcomes including vertebral height restoration and kyphotic deformity correction.
Visão geral do estudo
Status
Descrição detalhada
Background and Rationale:
Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns.
The Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief.
This is a prospective, open-label, randomized, parallel-controlled, non-inferiority clinical trial conducted in Taiwan to evaluate the safety and clinical effectiveness of this system (Model: BVFT-UP01-D20, Approved No. 005889) compared with conventional vertebroplasty performed using manual orthopedic surgical instruments (Approved No. 005698), both manufactured by CMT. Both groups will utilize the same radiopaque bone cement ("Tecres" Osteopal V) for the therapeutic procedures.
Hypothesis:
The study is designed as a non-inferiority trial. The primary hypothesis is that the incidence of unanticipated serious adverse device effects (USADEs) in the Vessel-X® group is not higher than that in the control group. For efficacy, the experimental group is hypothesized to be non-inferior to the control group regarding pain relief, disability improvement, and radiographic parameters, with a pre-specified non-inferiority margin of -15% for the difference in fused effective rates between the two groups.
Patient Enrollment and Site Allocation:
To achieve the clinical evaluation objectives, a total of up to 146 subjects will be recruited across participating medical centers in Taiwan. The target sample size is allocated specifically as 86 subjects from Tri-Service General Hospital (TSGH) and 60 subjects from Taoyuan General Hospital (TYGH). Subjects at each site will be allocated to the experimental and control groups using a 1:1 randomization scheme.
Surgical Procedure Protocol:
All surgical procedures will be performed under real-time fluoroscopic (C-arm) guidance using a standard unilateral transpedicular approach:
Experimental Group: The Vessel-X® PET biocompatible microporous container will be deployed into the vertebral body, and bone cement will be injected in a controlled manner, allowing partial cement interdigitation through the micropores. The container remains as a permanent implant.
Control Group: Conventional vertebroplasty will be performed using CMT's standard manual orthopedic surgical instruments to deliver the bone cement directly.
In both groups, fluoroscopic monitoring is maintained throughout the injection, and cement delivery will be discontinued immediately if any cement leakage or breach is observed.
Clinical Evaluation Timelines:
Subjects will participate in the study for a total duration of 13 months, consisting of a 1-month screening period, the surgical intervention (Day 1), and a 12-month post-operative follow-up period. Follow-up visits are scheduled at Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days).
Outcome Assessments:
Safety Assessment (Primary Endpoint, ITT Population): Evaluated by the incidence of adverse events, complications, bone cement leakage, and new-onset neurological deficits.
Efficacy Assessment (Secondary Endpoints, PP & FAS Populations): Evaluated by changes from baseline to each follow-up timepoint in Visual Analogue Scale (VAS) scores for pain, Oswestry Disability Index (ODI) scores for functional disability, and radiographic parameters (anterior vertebral height, midline vertebral height, and kyphotic Cobb's angle)
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Juin-Hong Cherng, Ph.D.
- Número de telefone: 18681, 18699 886-2-87923100
- E-mail: i72bbb@gmail.com
Estude backup de contato
- Nome: Gang-Yi Fan, Ph.D.
- Número de telefone: 18699 886-2-87923100
- E-mail: u9310318@gmail.com
Locais de estudo
-
-
-
Taipei, Taiwan, 114202
- Recrutamento
- Tri-Service General Hospital, National Defense Medical Univesity
-
Contato:
- Gang-Yi Fan, Ph.D.
- Número de telefone: 18699 886-2-87923100
- E-mail: u9310318@gmail.com
-
Contato:
- Juin-Hong Cherng, Ph.D.
- Número de telefone: 18698, 18699 886-2-87923100
- E-mail: i72bbb@gmail.com
-
Taipei, Taiwan, 11490
- Recrutamento
- National Defense Medical University, Taiwan
-
Contato:
- Gang-Yi Fan, Ph.D.
- Número de telefone: 18699 886-2-87923100
- E-mail: u9310318@gmail.com
-
Contato:
- Juin-Hong Cherng, Ph.D.
- Número de telefone: 18698, 18699 886-2-8792-3100
- E-mail: i72bbb@gmail.com
-
Investigador principal:
- Chih-Chern Wang, Ph.D.
-
Investigador principal:
- Yu-Hsu Chen, Ph.D.
-
Subinvestigador:
- Yi-Chou Chen, Ｍ.D.
-
Subinvestigador:
- Chien-Ning Hsu, Ｍ.D.
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for enrollment in this study:
- Male or female subjects aged ≥40 and ≤95 years.
- Subjects admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma.
- Surgical site within the range of T6 to L5.
- Subjects with normal vital signs and hepatic and renal function values within 1.5 times the upper limit of normal (ULN), as determined by the investigator to be suitable for study participation.
- Subjects willing to comply with the study schedule and all required assessment procedures.
- Subjects who are conscious, cognitively intact, and able to provide written informed consent.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from participation in this study:
- Pathological fractures caused by bone diseases, including benign or malignant tumors, tuberculosis, osteomyelitis, endocrine or metabolic bone disorders, or severe degenerative bone diseases.
- Active or severe systemic infections.
- Metabolic disorders (e.g., calcium metabolism disorders), immune system disorders, substance abuse, or alcoholism.
- Severe primary diseases involving the hematopoietic or endocrine systems, or psychiatric disorders.
- History of allergy to implant materials, hypersensitivity reactions, or allergies to multiple medications.
- Non-viable bone surrounding the surgical site or insufficient bone quality to support the implant.
- Active infection at or adjacent to the surgical site.
- Acute spinal instability.
- Unwillingness or inability to restrict physical activity or comply with medical instructions.
- Considered unsuitable for study participation by the investigator, or unable to provide independent informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: CMT Vessel-X ® Bone Filling Container System
Subjects undergo percutaneous vertebral augmentation using the CMT Vessel-X® Bone Filling Container System (Model: BVFT-UP01-D20).
Under fluoroscopic guidance, a unilateral transpedicular approach is used to access the fractured vertebral body.
The microporous PET Vessel-X® Bone Filling Container is deployed within the vertebral body and subsequently filled with TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z) to stabilize the vertebral compression fracture.
|
Model: BVFT-UP01-D20 (TFDA No. 005889, GMP0106), manufactured by Central Medical Technologies Inc. (marketed since Aug 2017). An EO-sterilized, single-use, implantable kit for percutaneous vertebral augmentation (store <= 25°C, shelf-life: 5 years). The kit includes:
|
|
Comparador Ativo: CMT Conventional Vertebroplasty
Subjects undergo percutaneous vertebroplasty using the CMT Manual Orthopedic Surgical Instruments (Model: T-C308).
Under real-time fluoroscopic guidance, a unilateral transpedicular approach is used to access the fractured vertebral body, and TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z) is directly injected into the vertebral body to stabilize the vertebral compression fracture.
|
The CMT Manual Orthopedic Surgical Instruments (Model: T-C308; TFDA License No. 005698) are nonimplantable manual surgical instruments intended for conventional vertebroplasty procedures.
The device functions as a manual cement delivery system for the injection of TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z; TFDA License No. 026888) into the vertebral body to stabilize vertebral compression fractures.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Adverse Events, Serious Adverse Events (SAEs), and Unanticipated Serious Adverse Device Effects (USADEs)
Prazo: Day 1 (post-op), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
The primary safety endpoint is to evaluate the safety profile of the "Central Medical" Vessel-X® Bone Filling Container System.
Safety assessments will analyze the incidence, specific manifestations, severity, and device-causality of all adverse events (AEs), serious adverse events (SAEs), and unanticipated serious adverse device effects (USADEs) following percutaneous vertebroplasty (including bone cement leakage, nerve root injury, vascular injury, or subsequent vertebral collapse).
Proportions of abnormal post-operative cases and complication incidence with 95% Confidence Intervals (CI) will be calculated using the Intent-to-Treat (ITT) population.
|
Day 1 (post-op), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Score
Prazo: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
Pain intensity will be assessed using the 100-mm Visual Analogue Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain.
Changes from baseline in VAS scores will be compared between the experimental and control groups to evaluate pain relief following treatment.
|
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
|
Change From Baseline in Oswestry Disability Index (ODI) Score
Prazo: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
Functional disability will be evaluated using the Oswestry Disability Index (ODI) questionnaire.
Changes from baseline in ODI scores will be compared between the experimental and control groups to assess functional recovery following treatment.
|
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
|
Change From Baseline in Radiographic Anterior Vertebral Height
Prazo: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
Radiographic assessment of anterior vertebral height (measured in millimeters) will be performed using X-ray, computed tomography (CT), or magnetic resonance imaging (MRI).
Changes from baseline will be compared between the experimental and control groups to evaluate vertebral body restoration.
|
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
|
hange From Baseline in Radiographic Mid-Vertebral Height
Prazo: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
Radiographic assessment of mid-vertebral height (measured in millimeters) will be performed using X-ray, computed tomography (CT), or magnetic resonance imaging (MRI).
Changes from baseline will be compared between the experimental and control groups to evaluate vertebral body restoration.
|
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
|
Change From Baseline in Kyphotic Cobb's Angle
Prazo: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
Radiographic assessment of the kyphotic Cobb's angle (measured in degrees) will be performed using sagittal X-ray, computed tomography (CT), or magnetic resonance imaging (MRI) to evaluate spinal alignment correction.
Changes from baseline will be compared between the experimental and control groups.
|
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dr. Chih-Chien Wang, Ph.D., Trial-Service General Hospital, National Defense Medical University
- Investigador principal: Yu-Hsu Chen, Ph.D., Taoyuan General Hospital, Ministry of Health and Welfare
Publicações e links úteis
Publicações Gerais
- Sun QC, Ru XL, Song BS, Duanmu QL. [Mid-term follow-up and coping strategies of bone cement leakage after percutaneous kyphoplasty]. Zhongguo Gu Shang. 2017 Sep 25;30(9):810-816. doi: 10.3969/j.issn.1003-0034.2017.09.006. Chinese.
- Vcelak J, Toth L, Slegl M, Suman R, Majernicek M. [Vertebroplasty and kyphoplasty--treatment of osteoporotic vertebral fractures]. Acta Chir Orthop Traumatol Cech. 2009 Feb;76(1):54-9. Czech.
- Papadopoulos EC, Edobor-Osula F, Gardner MJ, Shindle MK, Lane JM. Unipedicular balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures: early results. J Spinal Disord Tech. 2008 Dec;21(8):589-96. doi: 10.1097/BSD.0b013e31815d6997.
- Zheng Z, Luk KD, Kuang G, Li Z, Lin J, Lam WM, Cheung KM, Lu WW. Vertebral augmentation with a novel Vessel-X bone void filling container system and bioactive bone cement. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2076-82. doi: 10.1097/BRS.0b013e3181453f64.
- Sun Y, Xiong X, Wan D, Deng X, Shi H, Song S, Gu T, Hou W, Zhou J. [Comparison of effectiveness of Vesselplasty and percutaneous kyphoplasty for Kummell disease]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2020 Dec 15;34(12):1539-1544. doi: 10.7507/1002-1892.202007064. Chinese.
- Petersen A, Hartwig E, Koch EM, Wollny M. Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study. Eur J Orthop Surg Traumatol. 2016 Jan;26(1):67-75. doi: 10.1007/s00590-015-1711-5.
- Lee HM, Park SY, Lee SH, Suh SW, Hong JY. Comparative analysis of clinical outcomes in patients with osteoporotic vertebral compression fractures (OVCFs): conservative treatment versus balloon kyphoplasty. Spine J. 2012 Nov;12(11):998-1005. doi: 10.1016/j.spinee.2012.08.024. Epub 2012 Sep 29.
- Li X, Yang H, Tang T, Qian Z, Chen L, Zhang Z. Comparison of kyphoplasty and vertebroplasty for treatment of painful osteoporotic vertebral compression fractures: twelve-month follow-up in a prospective nonrandomized comparative study. J Spinal Disord Tech. 2012 May;25(3):142-9. doi: 10.1097/BSD.0b013e318213c113.
- Abdelgawaad AS, Ezzati A, Govindasamy R, Krajnovic B, Elnady B, Said GZ. Kyphoplasty for osteoporotic vertebral fractures with posterior wall injury. Spine J. 2018 Jul;18(7):1143-1148. doi: 10.1016/j.spinee.2017.11.001. Epub 2017 Nov 14.
- Lin J, Zhang L, Yang HL. Unilateral versus bilateral balloon kyphoplasty for osteoporotic vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):447-53.
- Liu JT, Li CS, Chang CS, Liao WJ. Long-term follow-up study of osteoporotic vertebral compression fracture treated using balloon kyphoplasty and vertebroplasty. J Neurosurg Spine. 2015 Jul;23(1):94-8. doi: 10.3171/2014.11.SPINE14579. Epub 2015 Apr 17.
- Pateder DB, Khanna AJ, Lieberman IH. Vertebroplasty and kyphoplasty for the management of osteoporotic vertebral compression fractures. Orthop Clin North Am. 2007 Jul;38(3):409-18; abstract vii. doi: 10.1016/j.ocl.2007.03.010.
- Ahsan MK, Pandit OP, Khan MSI. Percutaneous vertebroplasty for symptomatic osteoporotic compression fractures: A single-center prospective study. Surg Neurol Int. 2021 Apr 19;12:176. doi: 10.25259/SNI_212_2021. eCollection 2021.
- Afzal S, Dhar S, Vasavada NB, Akbar S. Percutaneous vertebroplasty for osteoporotic fractures. Pain Physician. 2007 Jul;10(4):559-63.
- Thillainadesan J, Schlaphoff G, Gibson KA, Hassett GM, McNeil HP. Long-term outcomes of vertebroplasty for osteoporotic compression fractures. J Med Imaging Radiat Oncol. 2010 Aug;54(4):307-14. doi: 10.1111/j.1754-9485.2010.02176.x.
- Yu W, Liang D, Jiang X, Ye L, Yao Z. [COMPARISON OF EFFECTIVENESS BETWEEN PERCUTANEOUS VERTEBROPLASTY AND PERCUTANEOUS KYPHOPLASTY FOR TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE WITH INTRAVERTEBRAL VACUUM CLEFT]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2016 Sep 8;30(9):1104-1110. doi: 10.7507/1002-1892.20160225. Chinese.
- Jindal V, Binyala S, Kohli SS. Balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral body compression fractures: clinical and radiological outcomes. Spine J. 2023 Apr;23(4):579-584. doi: 10.1016/j.spinee.2022.11.015. Epub 2022 Dec 5.
- Liu JT, Liao WJ, Tan WC, Lee JK, Liu CH, Chen YH, Lin TB. Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: a prospective, comparative, and randomized clinical study. Osteoporos Int. 2010 Feb;21(2):359-64. doi: 10.1007/s00198-009-0952-8. Epub 2009 Jun 10.
- Weber MA. [Vertebroplasty for long-term pain reduction in osteoporotic vertebral body compression fractures. What is proven and what is unclear?]. Radiologe. 2012 Jan;52(1):5-7. doi: 10.1007/s00117-011-2280-1. No abstract available. German.
- Tanigawa N, Kariya S, Komemushi A, Nakatani M, Yagi R, Kohzai M, Sawada S. Percutaneous vertebroplasty for osteoporotic compression fractures: long-term evaluation of the technical and clinical outcomes. AJR Am J Roentgenol. 2011 Jun;196(6):1415-8. doi: 10.2214/AJR.10.5586.
- Voormolen MH, Lohle PN, Lampmann LE, van den Wildenberg W, Juttmann JR, Diekerhof CH, de Waal Malefijt J. Prospective clinical follow-up after percutaneous vertebroplasty in patients with painful osteoporotic vertebral compression fractures. J Vasc Interv Radiol. 2006 Aug;17(8):1313-20. doi: 10.1097/01.RVI.0000231952.75209.4A.
- Pflugmacher R, Schulz A, Schroeder RJ, Schaser KD, Klostermann CK, Melcher I. [A prospective two-year follow-up of thoracic and lumbar osteolytic vertebral fractures caused by multiple myeloma treated with balloon kyphoplasty]. Z Orthop Ihre Grenzgeb. 2007 Jan-Feb;145(1):39-47. doi: 10.1055/s-2007-960502. German.
- Pflugmacher R, Kandziora F, Schroder R, Schleicher P, Scholz M, Schnake K, Haas N, Khodadadyan-Klostermann C. [Vertebroplasty and kyphoplasty in osteoporotic fractures of vertebral bodies -- a prospective 1-year follow-up analysis]. Rofo. 2005 Dec;177(12):1670-6. doi: 10.1055/s-2005-858631. German.
Links úteis
- Vertebral augmentation with a novel Vessel-X bone void filling container system and bioactive bone cement
- Vertebroplasty and kyphoplasty in osteoporotic fractures of vertebral bodies -- a prospective 1-year follow-up analysis
- A prospective two-year follow-up of thoracic and lumbar osteolytic vertebral fractures caused by multiple myeloma treated with balloon kyphoplast
- Prospective clinical follow-up after percutaneous vertebroplasty in patients with painful osteoporotic vertebral compression fractures
- Percutaneous vertebroplasty for osteoporotic compression fractures: long-term evaluation of the technical and clinical outcomes
- Vertebroplasty for long-term pain reduction in osteoporotic vertebral body compression fractures. What is proven and what is unclear?]
- doi: 10.1007/s00198-009-0952-8. Epub 2009 Jun 10. Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: a prospective, comparative, and randomized clinical study
- Balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral body compression fractures: clinical and radiological outcomes
- COMPARISON OF EFFECTIVENESS BETWEEN PERCUTANEOUS VERTEBROPLASTY AND PERCUTANEOUS KYPHOPLASTY FOR TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE WITH INTRAVERTEBRAL VACUUM CLEFT]
- Long-term outcomes of vertebroplasty for osteoporotic compression fractures
- Percutaneous vertebroplasty for osteoporotic fractures
- Percutaneous vertebroplasty for symptomatic osteoporotic compression fractures: A single-center prospective study
- Vertebroplasty and kyphoplasty for the management of osteoporotic vertebral compression fractures
- Long-term follow-up study of osteoporotic vertebral compression fracture treated using balloon kyphoplasty and vertebroplasty
- Unilateral versus bilateral balloon kyphoplasty for osteoporotic vertebral compression fractures
- Kyphoplasty for osteoporotic vertebral fractures with posterior wall injury
- Comparative analysis of clinical outcomes in patients with osteoporotic vertebral compression fractures (OVCFs): conservative treatment versus balloon kyphoplasty
- Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study
- Comparison of effectiveness of Vesselplasty and percutaneous kyphoplasty for Kümmell disease
- Unipedicular balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures: early results
- Vertebroplasty and kyphoplasty--treatment of osteoporotic vertebral fractures
- Mid-term follow-up and coping strategies of bone cement leakage after percutaneous kyphoplasty
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CMT-BVFT 2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .