RecruitingOBSERVATIONAL

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

This study is looking at a medical device named Ennovate® Cervical, which is used during neck surgery. Its main goal is to make sure the device is safe and works effectively for patients with various neck conditions. These conditions can include a broken neck bone, problems with the spongy discs between the bones (degenerative disc disease), spinal instability (when the spine moves too much), or even spinal tumors. The study closely monitors how patients are doing after their surgery with this device. It's a way for the manufacturer to gather important information directly from patients in a real-world setting, helping them understand the device's performance over time. This information is then used to ensure the device continues to meet high safety and effectiveness standards.

At a glance

Status

Recruiting

Sponsor

Aesculap AG

Enrolment target

200

Start

21 Jul 2021

Estimated completion

01 Jul 2026

Spine Fracture Degenerative Disc Disease Spinal Instability Spinal Tumor Degenerative Myelopathy

What is this study about?

This study is all about a special medical device called Ennovate® Cervical. This device is used by surgeons to help stabilise the neck or upper spine, particularly when someone has problems like a broken neck bone, worn-out discs between the bones (which can cause pain or numbness), or other issues that make the spine unstable. Imagine it like a support system for your neck after surgery.

The main purpose of this study is to keep a close eye on how well the Ennovate® Cervical device works and to make sure it's safe for patients. It's like a long-term check-up programme after the device has already been approved for use. By collecting information from many people who have this device, the manufacturers can learn valuable details about its performance in everyday situations. This helps them understand if it's doing its job effectively and if there are any unexpected issues over time.

Collecting this information is really important for both current patients and those who might need similar surgery in the future. It helps doctors and manufacturers ensure that the tools and implants used in surgery are as good and as safe as they can be. This ongoing monitoring helps to improve patient care and treatment quality.

Key takeaways

This study is checking the safety and performance of a neck implant called Ennovate® Cervical.
It helps gather important real-world information on how the device works for patients.
Your medical treatment won’t change if you participate; it's about collecting data from your routine care.
You must be at least 18 years old and having neck surgery where this device is used.
Participation is voluntary, and you can withdraw at any time without impacting your care.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must also be having surgery to treat a neck problem, where your doctor plans to use the Ennovate® Cervical device, and your situation must fit the approved uses for this device.

Before you start, you'll be asked to read and sign a form that says you understand what the study involves and that you agree for your medical information, including scans, to be used for the study. It's also very important that you are not pregnant at the time of your surgery and throughout the study.

There are a few reasons why you might not be able to take part. For example, if you have a medical condition that makes it impossible for you to come to follow-up appointments, or if you simply don't wish to take part in the long-term check-ups, then this study wouldn't be suitable for you.

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?
Are you having surgery on your neck or upper spine?
Will your surgeon be using the Ennovate® Cervical device?
Are you able and willing to attend your regular follow-up appointments?
Are you NOT pregnant?

Answer every question to see your result.

What does participation involve?

If you take part in this study, it actually won't change your surgery or medical care. You will still have your neck surgery as planned, and your doctor will use the Ennovate® Cervical device. What's different is that your medical team will collect information about your health and recovery more carefully and record it for the study. This includes details from your hospital visits, like your symptoms and how you're feeling, as well as results from any X-rays or scans you have done as part of your usual care. You won't need to take any new medicines just for the study, and your follow-up appointments will mostly be the same ones you'd have anyway after this type of surgery. The total duration of your participation will depend on how long your doctor usually monitors patients after this kind of procedure, but it's mainly about allowing your medical information to be used for the study over time.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of the Ennovate® Cervical device. Your information helps confirm its safety and effectiveness, which can improve care for future patients. There are no direct medical benefits to you beyond the surgical treatment you would receive anyway. As this study is mainly collecting information from your usual medical care, there are no extra risks involved beyond those typically associated with your surgery, which your doctor will explain in detail. You are always free to change your mind and withdraw from the study at any time without affecting your medical treatment.

Locations (4)

Krankenhaus Ludmillenstift Meppen
Verified postcode
Meppen, Germany· Not yet recruiting
Städtisches Klinikum Dresden
Verified postcode
Dresden, Germany· Not yet recruiting
Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale
Verified postcode
Halle, Germany· Recruiting
Schön Klinik Hamburg Eilbek
Verified postcode
Hamburg, Germany· Active not recruiting

Common questions

What is the Ennovate® Cervical device?

It's a medical implant used by surgeons to stabilise your neck or upper spine during an operation, helping to support bones that are broken or unstable.

Why is this study being done?

The study aims to check how safe and well the Ennovate® Cervical device performs in patients over time, gathering real-world information to make sure it's working as expected.

Will my treatment change if I join?

No, your surgery and medical care for your neck condition will be exactly the same whether you join the study or not. We're just collecting information from your standard care.

Do I have to attend extra appointments?

Generally, no. The study uses information from your regular follow-up appointments after surgery that you would have anyway. There shouldn't be extra visits just for the study.

Can I leave the study at any time?

Yes, taking part is completely voluntary. You can decide to withdraw from the study at any point, and it will not affect your medical care or relationship with your doctor.

How to find out more

Sarah Mattes

sarah.mattes@aesculap.de +497461950 Official trial record

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