Vessel-X Bone Filling Container System for Vertebral Augmentation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, randomized, parallel-controlled study conducted in Taiwan to compare the Vessel-X Bone Filling Container System with conventional vertebroplasty using manual instruments. It aims to determine safety and clinical effectiveness, focusing on pain, function, and vertebral height restoration while reducing cement leakage. Eligible participants are adults aged 40–95 with osteoporotic or traumatic vertebral compression fractures between T6 and L5. The device remains implanted within the vertebral body to potentially improve outcomes. Primary outcomes include adverse events and patient-reported measures, with non-inferiority to standard vertebroplasty as the benchmark.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for enrollment in this study:

1. Male or female subjects aged ≥40 and ≤95 years.
2. Subjects admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma.
3. Surgical site within the range of T6 to L5.
4. 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.
5. Subjects willing to comply with the study schedule and all required assessment procedures.
6. Subjects who are conscious, cognitively intact, and able to provide written informed consent.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in this study:

1. Pathological fractures caused by bone diseases, including benign or malignant tumors, tuberculosis, osteomyelitis, endocrine or metabolic bone disorders, or severe degenerative bone diseases.
2. Active or severe systemic infections.
3. Metabolic disorders (e.g., calcium metabolism disorders), immune system disorders, substance abuse, or alcoholism.
4. Severe primary diseases involving the hematopoietic or endocrine systems, or psychiatric disorders.
5. History of allergy to implant materials, hypersensitivity reactions, or allergies to multiple medications.
6. Non-viable bone surrounding the surgical site or insufficient bone quality to support the implant.
7. Active infection at or adjacent to the surgical site.
8. Acute spinal instability.
9. Unwillingness or inability to restrict physical activity or comply with medical instructions.
10. Considered unsuitable for study participation by the investigator, or unable to provide independent informed consent.

Where it's running

• Tri-Service General Hospital, National Defense Medical Univesity
  Taipei, Taiwan Recruiting
• National Defense Medical University, Taiwan
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Dr. Chih-Chien Wang, Ph.D. — Trial-Service General Hospital, National Defense Medical University
• Study coordinator: Juin-Hong Cherng, Ph.D.
• Email: i72bbb@gmail.com
• Phone: 886-2-87923100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.