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

NCT07665424 | Recruiting DMC

• 1 other identifier: CMT-BVFT 2026
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief 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

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)

Outcome Measures

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.

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Device: CMT Manual Orthopedic Surgical Instruments

Interventions

CMT Vessel-X® Bone Filling Container System DEVICE

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.

CMT Vessel-X ® Bone Filling Container System

CMT Manual Orthopedic Surgical Instruments DEVICE

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.

CMT Conventional Vertebroplasty

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juin-Hong Cherng: lead
• Tri-Service General Hospital: collaborator
• Taoyuan General Hospital: collaborator

Study Sites (2)

Tri-Service General Hospital, National Defense Medical Univesity

Taipei, 114202, Taiwan

RECRUITING

National Defense Medical University, Taiwan

Taipei, 11490, Taiwan

RECRUITING

Related Publications (23)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Abdelgawaad 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.

  PMID: 29154997 RESULT

• Lin J, Zhang L, Yang HL. Unilateral versus bilateral balloon kyphoplasty for osteoporotic vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):447-53.

  PMID: 24077191 RESULT

• Liu 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.

  PMID: 25884343 RESULT

• Pateder 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.

  PMID: 17629988 RESULT

• Ahsan 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.

  PMID: 34084604 RESULT

• Afzal S, Dhar S, Vasavada NB, Akbar S. Percutaneous vertebroplasty for osteoporotic fractures. Pain Physician. 2007 Jul;10(4):559-63.

  PMID: 17660854 RESULT

• Thillainadesan 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.

  PMID: 20718910 RESULT

• Yu W, Liang D, Jiang X, Ye L, Yao Z. [COMPARISON OF EFFECTIVENESS BETWEEN PERCUTANEOUS VERTEBROPLASTY AND PERCUTANEOUS KYPHOPLASTY FOR TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE WITH INTRAVERTEBRAL VACUUM CLEFT]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2016 Sep 8;30(9):1104-1110. doi: 10.7507/1002-1892.20160225. Chinese.

  PMID: 29786364 RESULT

• Jindal V, Binyala S, Kohli SS. Balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral body compression fractures: clinical and radiological outcomes. Spine J. 2023 Apr;23(4):579-584. doi: 10.1016/j.spinee.2022.11.015. Epub 2022 Dec 5.

  PMID: 36481681 RESULT

• Liu JT, Liao WJ, Tan WC, Lee JK, Liu CH, Chen YH, Lin TB. Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: a prospective, comparative, and randomized clinical study. Osteoporos Int. 2010 Feb;21(2):359-64. doi: 10.1007/s00198-009-0952-8. Epub 2009 Jun 10.

  PMID: 19513578 RESULT

• Weber MA. [Vertebroplasty for long-term pain reduction in osteoporotic vertebral body compression fractures. What is proven and what is unclear?]. Radiologe. 2012 Jan;52(1):5-7. doi: 10.1007/s00117-011-2280-1. No abstract available. German.

  PMID: 22249694 RESULT

• Tanigawa N, Kariya S, Komemushi A, Nakatani M, Yagi R, Kohzai M, Sawada S. Percutaneous vertebroplasty for osteoporotic compression fractures: long-term evaluation of the technical and clinical outcomes. AJR Am J Roentgenol. 2011 Jun;196(6):1415-8. doi: 10.2214/AJR.10.5586.

  PMID: 21606307 RESULT

• Voormolen MH, Lohle PN, Lampmann LE, van den Wildenberg W, Juttmann JR, Diekerhof CH, de Waal Malefijt J. Prospective clinical follow-up after percutaneous vertebroplasty in patients with painful osteoporotic vertebral compression fractures. J Vasc Interv Radiol. 2006 Aug;17(8):1313-20. doi: 10.1097/01.RVI.0000231952.75209.4A.

  PMID: 16923978 RESULT

• Pflugmacher R, Schulz A, Schroeder RJ, Schaser KD, Klostermann CK, Melcher I. [A prospective two-year follow-up of thoracic and lumbar osteolytic vertebral fractures caused by multiple myeloma treated with balloon kyphoplasty]. Z Orthop Ihre Grenzgeb. 2007 Jan-Feb;145(1):39-47. doi: 10.1055/s-2007-960502. German.

  PMID: 17345542 RESULT

• Pflugmacher R, Kandziora F, Schroder R, Schleicher P, Scholz M, Schnake K, Haas N, Khodadadyan-Klostermann C. [Vertebroplasty and kyphoplasty in osteoporotic fractures of vertebral bodies -- a prospective 1-year follow-up analysis]. Rofo. 2005 Dec;177(12):1670-6. doi: 10.1055/s-2005-858631. German.

  PMID: 16333790 RESULT

Related Links

• Vertebral augmentation with a novel Vessel-X bone void filling container system and bioactive bone cement
• Vertebroplasty and kyphoplasty in osteoporotic fractures of vertebral bodies -- a prospective 1-year follow-up analysis
• A prospective two-year follow-up of thoracic and lumbar osteolytic vertebral fractures caused by multiple myeloma treated with balloon kyphoplast
• Prospective clinical follow-up after percutaneous vertebroplasty in patients with painful osteoporotic vertebral compression fractures
• Percutaneous vertebroplasty for osteoporotic compression fractures: long-term evaluation of the technical and clinical outcomes
• Vertebroplasty for long-term pain reduction in osteoporotic vertebral body compression fractures. What is proven and what is unclear?\]
• doi: 10.1007/s00198-009-0952-8. Epub 2009 Jun 10. Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: a prospective, comparative, and randomized clinical study
• Balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral body compression fractures: clinical and radiological outcomes
• COMPARISON OF EFFECTIVENESS BETWEEN PERCUTANEOUS VERTEBROPLASTY AND PERCUTANEOUS KYPHOPLASTY FOR TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE WITH INTRAVERTEBRAL VACUUM CLEFT\]
• Long-term outcomes of vertebroplasty for osteoporotic compression fractures
• Percutaneous vertebroplasty for osteoporotic fractures
• Percutaneous vertebroplasty for symptomatic osteoporotic compression fractures: A single-center prospective study
• Vertebroplasty and kyphoplasty for the management of osteoporotic vertebral compression fractures
• Long-term follow-up study of osteoporotic vertebral compression fracture treated using balloon kyphoplasty and vertebroplasty
• Unilateral versus bilateral balloon kyphoplasty for osteoporotic vertebral compression fractures
• Kyphoplasty for osteoporotic vertebral fractures with posterior wall injury
• Comparative analysis of clinical outcomes in patients with osteoporotic vertebral compression fractures (OVCFs): conservative treatment versus balloon kyphoplasty
• Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study
• Comparison of effectiveness of Vesselplasty and percutaneous kyphoplasty for Kümmell disease
• Unipedicular balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures: early results
• Vertebroplasty and kyphoplasty--treatment of osteoporotic vertebral fractures
• Mid-term follow-up and coping strategies of bone cement leakage after percutaneous kyphoplasty

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dr. Chih-Chien Wang, Ph.D.

  Trial-Service General Hospital, National Defense Medical University

  PRINCIPAL INVESTIGATOR

• Yu-Hsu Chen, Ph.D.

  Taoyuan General Hospital, Ministry of Health and Welfare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juin-Hong Cherng, Ph.D.

CONTACT

886-2-87923100; i72bbb@gmail.com

Gang-Yi Fan, Ph.D.

CONTACT

886-2-87923100; u9310318@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 24, 2026
• Study Start: April 20, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)