The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 L
- •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.
排除标准
- •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.
研究者
Juin-Hong Cherng
Associate Professor
National Defense Medical Center, Taiwan