Active not recruitingNAINTERVENTIONAL

Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration

This pioneering study aims to assess the safety and effectiveness of a new device called the VCFix Spinal System. This system helps treat certain types of broken bones in the spine, specifically called vertebral compression fractures. This is a small, initial study involving only 10 participants across two hospitals in Europe. The main goal is to see if the surgical procedure for placing the VCFix device is successful and if the device itself reduces the fracture as planned. Researchers will also closely monitor for any serious side effects in the first 30 days after the operation. The results of this early study will help decide if more extensive research can be done in the future. Participants will be followed for two years.

At a glance

Status

Active not recruiting

Phase

Sponsor

Amber Implants B.V.

Enrolment target

Start

18 Sep 2023

Estimated completion

14 May 2026

Vertebral Compression Fracture

What is this study about?

This study is looking into a new way to treat a specific type of spinal fracture called a vertebral compression fracture. This happens when one of the bones in your spine (a vertebra) cracks or collapses, often causing significant pain. The new treatment involves a device called the VCFix Spinal System.

This is a very early-stage study, sometimes called a "proof-of-concept" study. Think of it like a first test drive of a new car. The main goal is to see if the VCFix system can be safely and effectively placed in the spine, and if it helps to mend the broken bone as intended. Researchers will be carefully observing the surgical process itself and how well the implant works to reduce the fracture. They will also be looking very closely for any serious side effects in the first month after surgery. This information is crucial for deciding if this device moves forward to larger studies.

This study is quite small, involving only 10 people in total across two hospitals. The participants will all receive the same surgery with the VCFix system. The information gathered from these few people will help researchers understand if the VCFix system is safe and promising enough to continue with more detailed and larger studies in the future, potentially leading to its wider availability.

Key takeaways

This is a small, early-stage study for a new spinal fracture treatment.
It aims to check the VCFix Spinal System's safety and how well it works.
Only 10 participants are involved, being followed for two years.
It's for people with a single, recent spinal fracture causing pain.
All side effects will be carefully monitored.
Results will help decide on future, larger studies.

Who may be eligible?

To be considered for this study, you would need to be between 22 and 85 years old. You must have a single, recent spinal fracture (less than 6 weeks old, or showing signs it can be fixed) in your upper or mid-back, which is causing you significant pain and some disability. Your fracture should have caused a loss of height in the spinal bone of at least 10% but no more than 70%.

Some things would mean you couldn't join the study. For example, if you have certain types of growths near your spine, if your fracture is old and can't be corrected, if you've had a spinal fracture before, or if you've already had a similar type of spine surgery. Also, if your pain is getting better with medicines alone, or if you have a condition affecting your spinal cord, you wouldn't be eligible. You also need to be able to understand the study and commit to all the appointments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 22 and 85 years old?
Do you have a single, recent break in your spine (less than 6 weeks old, or showing signs it can be fixed)?
Is your spinal fracture causing you significant back pain and affecting your daily life?
Have you NOT had a spinal fracture before, or previous spine surgery for a fracture?
Are you able to attend all study appointments over two years?
Do you understand the study and agree to its requirements?

Answer every question to see your result.

What does participation involve?

If you join the study, you will have surgery to implant the VCFix device into your broken spinal bone. Before the surgery, you'll have various scans and assessments to make sure the VCFix system is suitable for your specific fracture. The researchers will be looking at how successfully the device is put in place and how well it helps to reduce your fracture.

After the surgery, you'll be carefully monitored for 30 days to check for any major side effects. All side effects related to your spine will be recorded throughout the study. You will need to attend regular follow-up appointments for a total of two years after your surgery. The full process of enrolling participants will take about 12 months, and then everyone will be followed for two years. You'll need to be available for all these study visits.

Potential risks and benefits

Participating in a study like this could potentially offer you access to a new treatment for your spinal fracture that is not yet widely available. The main benefit researchers hope to see is that the VCFix system is a safe and effective way to help mend your broken spinal bone and reduce your pain. However, as with any new treatment or surgery, there are potential risks, including side effects related to the device or the procedure itself. Researchers will be monitoring these very closely. It's important to remember that this is an early-stage study, so the long-term benefits and risks are still being understood. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Wilhelmsburger Krankenhaus Groβ-Sand
Verified postcode
Hamburg, Germany
Krankenhaus Mechernich
Verified postcode
Mechernich, Germany

Common questions

What is a vertebral compression fracture?

It's when one of the bones in your spine (a vertebra) cracks or collapses, often because of weakness or injury.

What is the VCFix Spinal System?

It's a new medical device designed to help fix and stabilise broken bones in the spine.

How many people are in this study?

This is a very small study with only 10 participants in total across two hospitals.

How long will I be involved in the study?

You would be followed for two years after your surgery to implant the VCFix device.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.