Recruiting

Testing a new bone-filling container for spine fractures from osteoporosis

Plain-English translation of NCT07665424 on ClinicalTrials.gov ↗ · Source last updated ·

What is this trial?

This clinical trial is testing the Vessel-X® Bone Filling Container System, a new device designed to treat vertebral compression fractures—painful spine fractures that occur in people with osteoporosis. The system uses a small, biocompatible container that is filled with bone cement to stabilize the fractured vertebra and reduce pain. Researchers are comparing this new treatment to the standard spine-stabilization procedure to see if it is safer and works just as well or better.

Osteoporotic spine fractures cause severe pain and disability, especially in older adults and postmenopausal women. While standard procedures can help, they carry risks like cement leaking outside the vertebra and incomplete restoration of spine height. This trial is testing whether the new container system can reduce these risks while still relieving pain and restoring spine function.

Do you qualify?

You likely qualify if…

you are between 40 and 95 years old
you have a spine fracture caused by osteoporosis or trauma in your mid-to-lower back
you have normal kidney and liver function
you are able to understand the study and give written informed consent
you are willing to follow the study schedule and attend all appointments

You likely don't qualify if…

you have a spine fracture caused by cancer, infection, tuberculosis, or severe bone disease
you currently have an active infection anywhere in your body
you have a severe allergy to the materials in the implant or to common medications
you have severe or unstable conditions affecting your blood system, hormones, or mental health
you have acute spinal instability or are unable to limit physical activity after the procedure

What participation looks like

If you are selected for this trial, you will receive a minimally invasive procedure performed under real-time imaging guidance. Depending on which group you are randomly assigned to, you will either receive the new Vessel-X® container system filled with bone cement, or the standard vertebroplasty procedure using bone cement alone. Both procedures take place in an operating room, and you will be monitored for safety and symptom relief afterward through follow-up visits and assessments.

Testing a new bone-filling container for spine fractures from osteoporosis

What is this trial?

Do you qualify?

What participation looks like

Trial locations(2 sites)