BridgeMD
Tests treatment safety and results for Osteoporosis
Official title Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System
ClinicalTrials.gov ID: NCT07665424
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 95
You may be able to join if
- people must meet all of the following criteria to be eligible for enrollment in this study:
- Male or female people aged ≥40 and ≤95 years.
- people admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma.
- Surgical site within the range of T6 to L5.
- people with normal vital signs and hepatic and renal function values within 1.5 times the upper limit of normal (ULN), as determined by the...
You likely can't join if
- people 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...
- 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.
See the full eligibility criteria
- people must meet all of the following criteria to be eligible for enrollment in this study:
- Male or female people aged ≥40 and ≤95 years.
- people admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma.
- Surgical site within the range of T6 to L5.
- people 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.
- people willing to comply with the study schedule and all required assessment procedures.
- people who are conscious, cognitively intact, and able to provide written informed consent.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.