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Tests treatment safety and results for Vertebral Compression Fracture
Official title A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures
ClinicalTrials.gov ID: NCT07301749
What this study is testing
- What it's testing
- This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults. Up to 8 hospitals in Europe will take part in the study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 85
You may be able to join if
- Subject is ≥ 21 to ≤ 85 years old.
- Single vertebral fracture which meets all of the following criteria:
- Type A fractures from AO spine classification (compression injuries);
- Vertebral fracture located in the thoracic and lumbar regions of the spine
- Fracture age \< 6 weeks or fractures with anatomic signs of reducibility (based on radiographic evidence as well as patient history)
You likely can't join if
- Neoplasms with posterior involvement and/or presence of a mass within the spinal canal
- Non-mobile fractures (i.e., fracture is not recent (\>6 weeks), bone marrow edema or fluid or empty cleft are not visible in radiographic imaging, or...
- Spondylolisthesis \> Grade 1 at target vertebral body(s)
- Local kyphotic angle \> 30°
- Pre-existing vertebral fracture prior to the index fracture
- people that require anterior stabilization of the index fracture
See the full eligibility criteria
- Subject is ≥ 21 to ≤ 85 years old.
- Single vertebral fracture which meets all of the following criteria:
- Type A fractures from AO spine classification (compression injuries);
- Vertebral fracture located in the thoracic and lumbar regions of the spine
- Fracture age \< 6 weeks or fractures with anatomic signs of reducibility (based on radiographic evidence as well as patient history)
- Vertebral fracture shows an estimated height loss in the anterior or mid third of the vertebral body (VB) of at least 10% but not more than 60% based on radiographic evidence
- Target VB has appropriate anatomy, i.e. suitable pedicle diameter, pedicle length and chord length that would allow for selection of correct implant size, as described in the IFU and based on axial MRI/CT scan before...
- Subject has a NPRS back pain score of ≥5
- Subject is a candidate for surgical intervention based on investigator opinion
- Subject has a body Mass Index (BMI) \< 35
- Subject is mentally capable of complying with trial protocol requirements for the duration of the study
- Subject can understand the risks and benefits of participating in the study and is able to provide written informed consent
- Neoplasms with posterior involvement and/or presence of a mass within the spinal canal
- Non-mobile fractures (i.e., fracture is not recent (\>6 weeks), bone marrow edema or fluid or empty cleft are not visible in radiographic imaging, or fracture mode does not allow for fracture reduction in craniocaudal...
- Spondylolisthesis \> Grade 1 at target vertebral body(s)
- Local kyphotic angle \> 30°
- Pre-existing vertebral fracture prior to the index fracture
- people that require anterior stabilization of the index fracture
- Fracture to the pedicle based on radiographic evaluation
- Spinal cord compression or canal compromise requiring decompression
- Severe back pain due to causes other than acute fracture with NPRS score\>5
- The subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
- Pain due to any other condition that requires daily narcotic (opiates or opioids) medication
- Pre-existing neurological deficit, radiculopathy or myelopathy
- Pre-existing condition or significant co-morbidity:
- Uncontrolled diabetes (HbA1c \>8%)
- Severe cardiopulmonary deficiencies
- Any other condition that would impact study outcome in the opinion of the investigator
- Contraindications to both MRI and radionuclide bone scan
- Concurrent participation in another clinical study which could potentially interfere with the outcome of this study.
- A life expectancy less than the study duration or undergoing palliative care
- Subject non-ambulatory prior to fracture
- Allergy to any components of the device/instruments used during the procedure
- Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection
- Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfecta, Paget's disease, etc.)
- Any evidence of alcohol or drug abuse.
- Ongoing long-term steroid therapy (steroid dose ≥30 mg /day for \>3 months)
- The subject is currently on anti-cancer therapy or anti-HIV therapy
- Pregnancy or people with child-bearing potential that are unwilling to use contraception throughout the study duration
The study team makes the final eligibility decision.
Where it's taking place
- Chambéry, France
- Hamburg, Germany
- Mechernich, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 21 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chambéry, France; Hamburg, Germany; Mechernich, Germany. 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.