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

Summary

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.

Conditions

• Osteoporosis
• Osteoporotic Vertebral Compression Fractures

Interventions

DEVICE

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 controlled hydraulic delivery. 3. Percutaneous Access Tools: Includes 1pc Bone Access Needle (T-N201T), 1pc Guide Pin (T-P602), and 1pc Precision Drill (T-D401). * Intervention Cement: TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z; TFDA License No. 026888), used during vertebral augmentation procedures for injection into the affected vertebra to stabilize vertebral compression fractures.

DEVICE

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.

Sponsors & Collaborators

• Tri-Service General Hospital (TSGH)

  collaborator OTHER

• Taoyuan General Hospital

  collaborator OTHER_GOV

• Juin-Hong Cherng

  lead OTHER

Principal Investigators

• Dr. Chih-Chien Wang, Ph.D. · Trial-Service General Hospital, National Defense Medical University

• Yu-Hsu Chen, Ph.D. · Taoyuan General Hospital, Ministry of Health and Welfare

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-20

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Taiwan

Study Locations