OsteoporosisCMT-VXNCT07665424
Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System
A study testing CMT Vessel-X® Bone Filling Container System and CMT Manual Orthopedic Surgical Instruments in people with Osteoporosis and Osteoporotic Vertebral Compression Fractures, run by Juin-Hong Cherng at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Osteoporosis, Osteoporotic Vertebral Compression Fractures
- What is being tested?
- CMT Vessel-X® Bone Filling Container System and CMT Manual Orthopedic Surgical Instruments
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesTaiwan
- Study dates
- 20 Apr 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Tri-Service General Hospital, National Defense Medical Univesity
Taipei, 114202
Juin-Hong Cherng, Ph.D., 886-2-87923100 ext. 18698, 18699, i72bbb@gmail.com
Gang-Yi Fan, Ph.D., 886-2-87923100 ext. 18699, u9310318@gmail.com
- Recruiting
National Defense Medical University, Taiwan
Taipei, 11490
Juin-Hong Cherng, Ph.D., 886-2-8792-3100 ext. 18698, 18699, i72bbb@gmail.com
Gang-Yi Fan, Ph.D., 886-2-87923100 ext. 18699, u9310318@gmail.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
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)
- Being tested
- CMT Vessel-X® Bone Filling Container System, CMT Manual Orthopedic Surgical Instruments
- Keywords
- Oswestry Disability Index, Visual Analogue Scale, Serious Adverse Device Effect, Last Observation Carry Forward, CMT Vessel-X® Bone Filling Container System, Vesselplasty, Kyphoplasty, Vertebroplasty, Osteoporotic vertebral compression fractures (OVCFs)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMT Vessel-X® Bone Filling Container SystemDevice
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:
- Vessel-X® Bone Filling Container (Model: BVFX-D20): An implantable, microporous PET container to enclose cement and minimize leakage.
- Front-Opening Cement Injection Device with Extension Tube (Model: T-C308, max 20 ml): For controlled hydraulic delivery.
- 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 InstrumentsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CMT Vessel-X ® Bone Filling Container System | Experimental | 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. Receives: Device: CMT Vessel-X® Bone Filling Container System |
| CMT Conventional Vertebroplasty | Active comparator | 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. Receives: Device: CMT Manual Orthopedic Surgical Instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (5)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start20 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, parallel-group, active-controlled interventional clinical trial conducted in Taiwan. Eligible participants diagnosed with osteoporotic vertebral compression fractures are randomized in a 1:1 ratio to receive either the CMT Vessel-X® Bone Filling Container System or CMT conventional percutaneous vertebroplasty using standard manual orthopedic surgical instruments. The study uses a parallel design with no crossover between treatment arms. Both groups undergo standardized unilateral transpedicular percutaneous vertebral augmentation under fluoroscopic guidance, with identical perioperative care and follow-up schedules. Participants are followed for 12 months post-operatively, with assessments of safety and clinical effectiveness. Primary focus is safety, while secondary outcomes include pain reduction (VAS), functional improvement (ODI), and radiographic vertebral restoration.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juin-Hong Cherng
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), Taoyuan General Hospital
- Responsible party
- Sponsor-investigator, Juin-Hong Cherng, National Defense Medical Center, Taiwan
- Investigators
- Dr. Chih-Chien Wang, Ph.D., Principal investigator, Trial-Service General Hospital, National Defense Medical UniversityYu-Hsu Chen, Ph.D., Principal investigator, Taoyuan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665424
- Sponsor's protocol ID
- CMT-BVFT 2026
- Acronym
- CMT-VX
- Status last verified
- May 2026
- First submitted
- 3 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant privacy and comply with institutional review board (IRB) restrictions and local data protection regulations.
Publications
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.
PubMed 29455481Vcelak 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.
PubMed 19268050Papadopoulos 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.
PubMed 19057254Zheng 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.
PubMed 17762808Sun 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.
PubMed 33319532Petersen 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.
PubMed 26482590Lee 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.
PubMed 23026068Li 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.
PubMed 21423053Abdelgawaad 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.
PubMed 29154997Lin J, Zhang L, Yang HL. Unilateral versus bilateral balloon kyphoplasty for osteoporotic vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):447-53.
PubMed 24077191Liu 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.
PubMed 25884343Pateder 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.
PubMed 17629988Ahsan 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.
PubMed 34084604Afzal S, Dhar S, Vasavada NB, Akbar S. Percutaneous vertebroplasty for osteoporotic fractures. Pain Physician. 2007 Jul;10(4):559-63.
PubMed 17660854Thillainadesan 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.
PubMed 20718910
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System
- ClinicalTrials.gov ID
- NCT07665424
- Acronym / sponsor ID
- CMT-VX / CMT-BVFT 2026
- Keywords
- Oswestry Disability Index, Visual Analogue Scale, Serious Adverse Device Effect, Last Observation Carry Forward, CMT Vessel-X® Bone Filling Container System, Vesselplasty, Kyphoplasty, Vertebroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Juin-Hong CherngUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), Taoyuan General Hospital
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel-group, active-controlled interventional clinical trial conducted in Taiwan. Eligible participants diagnosed with osteoporotic vertebral compression fractures are randomized in a 1:1 ratio to receive either the CMT Vessel-X® Bone Filling Container System or CMT conventional percutaneous vertebroplasty using standard manual orthopedic surgical instruments. The study uses a parallel design with no crossover between treatment arms. Both groups undergo standardized unilateral transpedicular percutaneous vertebral augmentation under fluoroscopic guidance, with identical perioperative care and follow-up schedules. Participants are followed for 12 months post-operatively, with assessments of safety and clinical effectiveness. Primary focus is safety, while secondary outcomes include pain reduction (VAS), functional improvement (ODI), and radiographic vertebral restoration.
| Arm | Type | Receives |
|---|---|---|
| CMT Vessel-X ® Bone Filling Container System | Experimental | Device: CMT Vessel-X® Bone Filling Container SystemSubjects 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. |
| CMT Conventional Vertebroplasty | Active comparator | Device: CMT Manual Orthopedic Surgical InstrumentsSubjects 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. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMT Vessel-X® Bone Filling Container SystemModel: 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 Vessel-X ® Bone Filling Container System |
| CMT Manual Orthopedic Surgical InstrumentsThe 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. | Device | CMT Conventional Vertebroplasty |
Primary outcome
Incidence of Adverse Events, Serious Adverse Events (SAEs), and Unanticipated Serious Adverse Device Effects (USADEs)
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.
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.
5 secondary outcomes
Change From Baseline in Visual Analogue Scale (VAS) Pain Score
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.
Change From Baseline in Oswestry Disability Index (ODI) Score
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.
Change From Baseline in Radiographic Anterior Vertebral Height
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.
hange From Baseline in Radiographic Mid-Vertebral Height
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.
Change From Baseline in Kyphotic Cobb's Angle
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Results publication: PubMed 29455481Sun 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.
- Results publication: PubMed 19268050Vcelak 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.
- Results publication: PubMed 19057254Papadopoulos 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.
- Results publication: PubMed 17762808Zheng 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.
- Results publication: PubMed 33319532Sun 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.
- Results publication: PubMed 26482590Petersen 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.
- Results publication: PubMed 23026068Lee 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.
- Results publication: PubMed 21423053Li 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.
- Results publication: PubMed 29154997Abdelgawaad 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.
- Results publication: PubMed 24077191Lin J, Zhang L, Yang HL. Unilateral versus bilateral balloon kyphoplasty for osteoporotic vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):447-53.
- Results publication: PubMed 25884343Liu 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.
- Results publication: PubMed 17629988Pateder 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.
- Vertebral augmentation with a novel Vessel-X bone void filling container system and bioactive bone cementLink provided by the sponsor.
- Vertebroplasty and kyphoplasty in osteoporotic fractures of vertebral bodies -- a prospective 1-year follow-up analysisLink provided by the sponsor.
- A prospective two-year follow-up of thoracic and lumbar osteolytic vertebral fractures caused by multiple myeloma treated with balloon kyphoplastLink provided by the sponsor.
- Prospective clinical follow-up after percutaneous vertebroplasty in patients with painful osteoporotic vertebral compression fracturesLink provided by the sponsor.
- Percutaneous vertebroplasty for osteoporotic compression fractures: long-term evaluation of the technical and clinical outcomesLink provided by the sponsor.
- Vertebroplasty for long-term pain reduction in osteoporotic vertebral body compression fractures. What is proven and what is unclear?\]Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant privacy and comply with institutional review board (IRB) restrictions and local data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Chih-Chien Wang, Ph.D. principal investigator
Trial-Service General Hospital, National Defense Medical University
Yu-Hsu Chen, Ph.D. principal investigator
Taoyuan General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMT Vessel-X® Bone Filling Container System and CMT Manual Orthopedic Surgical Instruments in people with Osteoporosis and Osteoporotic Vertebral Compression Fractures, run by Juin-Hong Cherng at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juin-Hong Cherng, Ph.D. (886-2-87923100 ext. 18681, 18699, i72bbb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Serious Adverse Events (SAEs), and Unanticipated Serious Adverse Device Effects (USADEs) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07665424, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.