Testing a New Spinal Implant for Compression Fractures

Plain-English translation of NCT07301749 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study is testing a medical device called VCFix designed to treat vertebral compression fractures—breaks in the spine that cause the vertebra to collapse or lose height. Up to 148 adults at 8 hospitals in Europe will receive surgery to implant the VCFix device. Some participants will have the device placed with special bone cement, while others will have it placed without cement, so researchers can see which approach works best.

Vertebral compression fractures are painful and can make everyday activities difficult. Doctors need to know whether this new implant device can reduce pain and improve function safely, and whether using bone cement with the device makes a difference.

Do you qualify?

You likely qualify if…

you are between 21 and 85 years old
you have a single recent compression fracture in the middle or lower spine that has caused 10–60% height loss
your back pain score is at least 5 on a 10-point scale
you have a BMI under 35
you are mentally able to follow the study plan and can provide informed consent
your doctor believes surgery is appropriate for your fracture

You likely don't qualify if…

you have cancer involving your spine or spinal canal
your fracture is very old (over 6 weeks) and not moveable
you have severe spine problems like slip (spondylolisthesis) or extreme curvature (kyphosis) that need different treatment
you have neurological problems like numbness, weakness, or paralysis related to your spine
you have uncontrolled diabetes, severe heart or lung disease, or other major health conditions that could affect healing

What participation looks like

You will have surgery to implant the VCFix device into your fractured vertebra. Depending on which group you're assigned to, the device will be placed with or without bone cement. After surgery, researchers will check your pain and ability to do daily activities at 6 months, and monitor you for any serious complications during the first month. The study will track your recovery to see how well the implant works and whether it is safe.

AI-generated summary from trial data · Jun 30, 2026 · Not medical advice

Testing a New Spinal Implant for Compression Fractures

What is this trial?

Do you qualify?

What participation looks like

Trial locations(3 sites)