Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System (CMT-VX)
22 giugno 2026 aggiornato da: Juin-Hong Cherng
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.
Panoramica dello studio
Stato
Stato
Reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
146
Fase
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Juin-Hong Cherng, Ph.D.
- Numero di telefono: 18681, 18699 886-2-87923100
- Email: i72bbb@gmail.com
Backup dei contatti dello studio
- Nome: Gang-Yi Fan, Ph.D.
- Numero di telefono: 18699 886-2-87923100
- Email: u9310318@gmail.com
Luoghi di studio
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Taipei, Taiwan, 114202
- Reclutamento
- Tri-Service General Hospital, National Defense Medical Univesity
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Contatto:
- Gang-Yi Fan, Ph.D.
- Numero di telefono: 18699 886-2-87923100
- Email: u9310318@gmail.com
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Contatto:
- Juin-Hong Cherng, Ph.D.
- Numero di telefono: 18698, 18699 886-2-87923100
- Email: i72bbb@gmail.com
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Taipei, Taiwan, 11490
- Reclutamento
- National Defense Medical University, Taiwan
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Contatto:
- Gang-Yi Fan, Ph.D.
- Numero di telefono: 18699 886-2-87923100
- Email: u9310318@gmail.com
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Contatto:
- Juin-Hong Cherng, Ph.D.
- Numero di telefono: 18698, 18699 886-2-8792-3100
- Email: i72bbb@gmail.com
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Investigatore principale:
- Chih-Chern Wang, Ph.D.
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Investigatore principale:
- Yu-Hsu Chen, Ph.D.
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Sub-investigatore:
- Yi-Chou Chen, Ｍ.D.
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Sub-investigatore:
- Chien-Ning Hsu, Ｍ.D.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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.
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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:
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Comparatore attivo: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incidence of Adverse Events, Serious Adverse Events (SAEs), and Unanticipated Serious Adverse Device Effects (USADEs)
Lasso di tempo: 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.
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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.
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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.
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change From Baseline in Visual Analogue Scale (VAS) Pain Score
Lasso di tempo: 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.
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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.
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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.
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Change From Baseline in Oswestry Disability Index (ODI) Score
Lasso di tempo: 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.
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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.
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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.
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Change From Baseline in Radiographic Anterior Vertebral Height
Lasso di tempo: 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.
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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.
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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.
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hange From Baseline in Radiographic Mid-Vertebral Height
Lasso di tempo: 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.
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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.
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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.
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Change From Baseline in Kyphotic Cobb's Angle
Lasso di tempo: 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.
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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.
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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.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Dr. Chih-Chien Wang, Ph.D., Trial-Service General Hospital, National Defense Medical University
- Investigatore principale: Yu-Hsu Chen, Ph.D., Taoyuan General Hospital, Ministry of Health and Welfare
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
- 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
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
20 aprile 2021
Completamento primario (Stimato)
Completamento primario
31 dicembre 2026
Completamento dello studio (Stimato)
Completamento dello studio
31 dicembre 2026
Date di iscrizione allo studio
Primo inviato
Primo inviato
3 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
22 giugno 2026
Primo Inserito (Effettivo)
Primo Inserito
24 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
24 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 giugno 2026
Ultimo verificato
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- CMT-BVFT 2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
IPD will not be shared to protect participant privacy and comply with institutional review board (IRB) restrictions and local data protection regulations.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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