RecruitingNAINTERVENTIONAL

Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

This study is gathering real-world information about a new type of artificial disc for the neck, called MOVE®-C, after it's been used in patients. The main goal is to make sure it's safe and works as expected for people with neck issues like slipped or worn discs, which can cause pain in the neck and arms. Researchers also want to see how this disc affects a patient's quality of life – meaning how well they can do everyday activities and how much it reduces their pain. We're also tracking how well people can move their neck after getting the disc. This is a large study involving many different medical centres.

At a glance

Status

Recruiting

Phase

Sponsor

NGMedical GmbH

Enrolment target

170

Start

11 Mar 2021

Estimated completion

11 Mar 2027

Discopathy Herniated Cervical Disc Stenoses, Spinal Radiculopathy

What is this study about?

This study is about a medical device called MOVE®-C, which is a replacement disc for the neck. You can think of it like a small cushion between the bones in your neck (vertebrae). When these natural discs get worn down or slip out of place, they can cause a lot of pain in your neck and sometimes down your arms. This is often called discopathy, a herniated disc, or stenosis.

The MOVE®-C disc is designed to replace a damaged disc and help you keep your neck moving naturally. This particular study is called a "Post Market Clinical Follow-up Study." This means the device has already been approved for use, and now doctors want to collect more information about how it performs in a real-world setting. They are especially interested in seeing if it continues to be safe and effective over time for people who have received it.

The main goals are to confirm the safety and effectiveness of the MOVE®-C disc. This includes looking at how it helps with pain, how it affects a person's quality of life (their general well-being and ability to live normally), and how well their neck moves after surgery. The information collected from this study will help healthcare professionals better understand the long-term benefits for patients.

Key takeaways

The study is checking how a neck disc replacement (MOVE®-C) performs after surgery.
It aims to confirm the device's safety and how well it helps with neck movement and quality of life.
It's for adults with long-term neck or arm pain from disc problems, where other treatments haven't worked.
You'll have regular check-ups and assessments after the surgery if you join.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to take part in this study, you would typically need to be at least 18 years old and have been diagnosed with certain neck problems, such as a slipped disc or a trapped nerve, which are causing pain in your neck or arms, or affecting your movement. It's important that your neck pain and symptoms have been ongoing for some time and that other treatments, like painkillers or physiotherapy, haven't worked in the last six weeks. You also shouldn't have had any recent neck surgery in the last six weeks before potentially joining the study.

There are also reasons why you might not be able to join. For example, if you have very weak bones (osteoporosis), an active infection, certain types of cancer affecting the spine, or if you're pregnant, this study wouldn't be suitable. You also can't take part if you have a known allergy to the materials used in the disc (titanium or polycarbonate-urethane) or if your spine needs special treatment that would make it unstable. Serious problems with your spinal cord or severe existing neck deformities would also prevent you from participating.

Finally, you must be able to understand the study, agree to take part in writing, and participate fully in all required appointments and assessments. This ensures that you are comfortable with what joining the study means.

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 18 years old or older?
Do you have ongoing neck or arm pain from a diagnosed neck disc problem?
Have other treatments for your neck pain not worked in the last six weeks?
Have you not had neck surgery in the last six weeks?
Do you not have active infections, very weak bones (osteoporosis), or certain severe spine conditions?
Are you able to understand and agree to take part in the study and attend all appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first need to have the MOVE®-C disc implanted during a surgical procedure. After the surgery, you would have regular check-ups with the study team. These check-ups will involve doctors assessing your neck's movement and your general recovery. You'll also likely be asked to fill out questionnaires about your pain levels and how your quality of life is improving over time. The study aims to follow how you are doing over a period of time, although the exact number and frequency of visits aren't detailed here. This allows the researchers to gather comprehensive information on the long-term safety and performance of the disc.

Potential risks and benefits

Participating in this study might offer the benefit of potentially reducing your neck and arm pain and improving your ability to move your neck and your overall quality of life, if the MOVE®-C disc is a suitable treatment for you. As with any surgery, there are always potential risks, such as infection, problems with recovery, or issues related to the implant itself, though the device has already been approved for use. All potential risks would be fully explained to you before you agree to take part. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Wiener Gesundheitsverbund-Klinik Penzing
Verified postcode
Vienna, Austria· Recruiting
DRK Klinikum Berlin
Verified postcode
Berlin, Germany· Recruiting
Wirbelsäulenzentrum Fulda Main, Kinzig
Verified postcode
Gelnhausen, Germany· Recruiting
Medizinisches Versorgungszentrum Steinburg
Verified postcode
Itzehoe, Germany· Recruiting
Katholisches Klinikum Koblenz - Montabaur
Verified postcode
Koblenz, Germany· Recruiting
Neurochirurgie am Gasteig
Verified postcode
München, Germany· Recruiting
Rhein-Maas Klinikum Würselen
Verified postcode
Würselen, Germany· Recruiting

Common questions

What is theMOVE®-C disc?

It's an artificial disc designed to replace a damaged disc in your neck, aiming to relieve pain and help you move normally.

Why is this study happening?

Doctors want to learn more about how well the MOVE®-C disc works and if it's safe for people in the long run after it's been used in real patients.

What kind of neck problems does this study focus on?

It's for people with pain in their neck or arms caused by issues like a slipped disc or trapped nerves in their neck.

Will I have to pay to be in the study?

Generally, legitimate clinical trials cover the costs of the study-related treatment and appointments. This would be confirmed with the study team.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your future medical care.

How to find out more

Saskia Mathieu, M.Sc.

smathieu@ngmedical.de +49687399997118 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.