Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System

Официальное название

The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System

Обзор

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.

Подробное описание

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)

Вмешательства

• Устройство CMT Vessel-X® Bone Filling Container System
  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: 1. Vessel-X® Bone Filling Container (Model: BVFX-D20): An implantable, microporous PET container to enclose cement and minimize leakage. 2. Front-Opening Cement Injection Device with Extension Tube (Model: T-C308, max 20 ml): For
• Устройство CMT Manual Orthopedic Surgical Instruments
  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.

Первичные конечные точки

• Incidence of Adverse Events, Serious Adverse Events (SAEs), and Unanticipated Serious Adverse Device Effects (USADEs) [Срок оценки: 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.]

Вторичные конечные точки (5)

• Change From Baseline in Visual Analogue Scale (VAS) Pain Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 2 центра

• Tri-Service General Hospital, National Defense Medical Univesity — Taipei
• National Defense Medical University, Taiwan — Taipei

Публикации

• 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. PMID 29455481
• 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. PMID 19268050
• 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. PMID 19057254
• 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. PMID 17762808
• 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. PMID 33319532
• 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. PMID 26482590
• 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. PMID 23026068
• 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. PMID 21423053

Идентификаторы

NCT: NCT07665424 · CMT-BVFT 2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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