Real-world safety study of VCFix device for spine fractures

Plain-English translation of NCT07920484 on ClinicalTrials.gov ↗ · Source last updated November 2026 · Translation generated November 2026 · How we translate trials

What is this trial?

This is a real-world study of the VCFix spinal system, a device designed to repair a broken vertebra (backbone) caused by osteoporosis. Researchers at about 5 hospitals across the U.S. will follow patients who receive this implant to learn how safe and effective it is when used in everyday clinical practice.

Vertebral compression fractures from weak bones (osteoporosis) can cause severe back pain and disability. This study exists to gather real-world evidence about how well the VCFix implant works and how safe it is for patients, helping doctors make better treatment decisions.

Do you qualify?

You likely qualify if…

you are between 21 and 85 years old
you have a single broken vertebra in your mid-back or lower back from weak bones or osteoporosis
your fracture occurred within the last 6 weeks, or shows signs it can be corrected based on X-rays or imaging
your broken vertebra has lost between 10% and 60% of its height
you have significant back pain (rated 5 or higher on a pain scale)
your spine's anatomy is suitable for this implant based on imaging scans

You likely don't qualify if…

you have cancer involving the spine or a mass in your spinal canal
you've had previous spine surgery, including kyphoplasty or vertebroplasty
you have severe slipping of one vertebra over another (spondylolisthesis)
you have significant spinal cord compression or nerve damage requiring surgery
you have uncontrolled diabetes, severe heart or lung problems, or other serious health conditions that could affect your safety

What participation looks like

You would undergo surgery to have the VCFix implant placed in your broken vertebra. After surgery, you would attend follow-up visits at the hospital to allow researchers to monitor your recovery, check your pain levels, and assess how well the implant is working over time. The study will track your progress to gather real-world safety and effectiveness data.

AI-generated summary from trial data · Nov 5, 2026 · Not medical advice

Real-world safety study of VCFix device for spine fractures

What is this trial?

Do you qualify?

What participation looks like

Trial locations(3 sites)