RecruitingNAINTERVENTIONAL

Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement

This research study is investigating a new surgical method called the Ennovate® Minimally Invasive technique. It's designed for people who need screws placed in their neck bones (known as pedicle screws) due to conditions affecting their neck, like pain. The main goal is to see if this newer, less invasive approach is as safe and effective as the traditional open surgery using the same Ennovate® Cervical Spinal System. Researchers will be collecting information on how patients benefit from the new procedure and if there are any risks or complications, comparing it directly to the well-established open surgical method. This will help understand if the minimally invasive method could be a good option for future patients.

At a glance

Status

Recruiting

Phase

Sponsor

Aesculap AG

Enrolment target

Start

20 Jun 2025

Estimated completion

01 Nov 2028

Cervical Spine Disease Pain, Postoperative

What is this study about?

This study is looking at a new way to help people with neck problems, specifically those who need surgery to stabilise their neck bones. Sometimes, doctors need to put small screws, called pedicle screws, into the bones of the neck (the cervical spine) to help them heal or stay firm. This can happen if you have a condition causing neck pain or instability.

The Ennovate® Minimally Invasive method is a newer surgical approach that uses smaller cuts than traditional open surgery. This study wants to find out if this less invasive technique is just as good, or even better, than the current standard open surgery. They want to check if it's safe for patients and if it helps them recover well and feel better, while still providing the necessary support to the neck bones. Both methods use the same special Ennovate® Cervical Spinal System to fix the screws.

By comparing these two surgical techniques, the researchers hope to gather important information. This will help them understand if the new, less invasive surgery offers benefits like faster recovery, less pain after the operation, or fewer complications. The goal is to ensure that future patients needing this type of neck surgery have access to the best and safest treatment options available.

Key takeaways

This study compares two ways to do neck surgery: a new 'minimally invasive' method and the standard 'open' surgery.
It aims to see if the new method is safe and effective for people needing neck bone stabilisation.
Participants must be over 18 and having specific neck screw surgery.
You will be closely monitored after surgery if you take part.
It's about finding the best and safest surgical options for future patients with neck problems.

Who may be eligible?

To join this study, you need to be at least 18 years old and be having surgery to place Ennovate® Cervical screws in your neck, specifically between the C2 and Th3 vertebrae, to help make your neck stable.

However, some things would mean you couldn't take part. For example, if you're unable or unwilling to sign a consent form, or if you know you won't be able to come to all the follow-up appointments, you wouldn't be able to join. Also, if your bones are very weak (like with severe osteoporosis), or you have bone diseases, bone tumours, or an infection in your spine, this study wouldn't be suitable for you. If you have an allergy to the materials used in the implant system, you also couldn't participate.

Finally, if it would be difficult for you to follow medical instructions, especially after surgery regarding movement and activity restrictions, this study might not be the right fit. This is because following these instructions is very important for proper healing and to ensure the surgery is successful.

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 need screws placed in your neck bones (C2-Th3) for stability?
Are you able and willing to sign a consent form and attend all follow-up appointments?
Do you have strong enough bones for the implant?
Do you have any allergies to common implant materials?
Are you able to follow medical instructions after surgery?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would undergo either the new minimally invasive surgery or the standard open surgery for your neck. You wouldn’t get to choose which method you receive. After your surgery, you would have a series of routine follow-up appointments so the doctors can check on your recovery and how well the surgery has worked. These appointments are important for monitoring your progress and ensuring the safety of the treatment. The total duration of your participation would depend on the standard follow-up schedule for your type of neck surgery, during which your health and the success of the procedure would be carefully assessed. You'd be expected to attend all scheduled visits.

Potential risks and benefits

Potential benefits of taking part could include receiving a potentially less invasive surgical technique, which might lead to a faster recovery or less pain after surgery compared to traditional methods, though this is what the study aims to find out. As with any surgery, there are potential risks, including infection, pain, complications from anaesthesia, and issues with the implant, some of which are listed in the exclusion criteria. You will be fully informed of all known and potential risks during the consent process. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (3)

Universitätsklinikum Aachen
Verified postcode
Aachen, Germany· Recruiting
Charité Berlin
Verified postcode
Berlin, Germany· Recruiting
Universitätsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting

Common questions

What problem is this study trying to solve?

It's comparing a new, less invasive neck surgery with the standard open surgery to see which is safer and works better for patients with certain neck conditions.

Who can take part in this study?

Adults over 18 who need a specific type of screw placed in their neck bones for stability.

What does 'minimally invasive' mean?

It means the surgery uses smaller cuts, which often leads to less pain and a quicker recovery than traditional open surgery.

Will I get to choose which surgery I have?

No, if you join the study, you will be assigned to either the new minimally invasive surgery or the standard open surgery by chance.

What if I change my mind after joining?

You are free to leave the study at any time, and it won't affect your medical care.

How to find out more

Sarah Mattes

studies@aesculap.de +497461 Official trial record

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