Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-95
SponsorJuin-Hong Cherng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CMT Vessel-X® Bone Filling Container System
DeviceModel: 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.
CMT Manual Orthopedic Surgical Instruments
DeviceThe 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.
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: CMT Vessel-X ® Bone Filling Container SystemExperimental treatment 1 intervention
Group B: CMT Conventional VertebroplastyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events, Serious Adverse Events (SAEs), and Unanticipated Serious Adverse Device Effects (USADEs)
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.
Time frame
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.Secondary outcomes
1
Change From Baseline in Visual Analogue Scale (VAS) Pain Score
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.
Time frame
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.2
Change From Baseline in Oswestry Disability Index (ODI) Score
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.
Time frame
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.3
Change From Baseline in Radiographic Anterior Vertebral Height
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.
Time frame
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.4
hange From Baseline in Radiographic Mid-Vertebral Height
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.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Juin-Hong Cherng
Lead sponsor
National Defense Medical Center, Taiwan
Sponsor institution
Tri-Service General Hospital
Collaborator
Taoyuan General Hospital
Collaborator
Source ClinicalTrials.gov