Not yet recruitingPhase IVInterventional

Evaluation of the performance and safety of the SCARLET® AC-Ti interbody cage after surgery of the cervical spine

This study is evaluating a medical device called SCARLET® AC-Ti, which is used in common neck surgery for people with ongoing neck pain or arm pain caused by worn-out discs or joint changes in their neck. This type of surgery, called ACDF, involves removing a damaged disc and joining the bones together. The study aims to see how well this device performs and how safe it is in real patients after surgery. Researchers will track patients over two years, looking at how well their bones fuse, how their pain improves, and their overall recovery. This will help understand the device's effectiveness and safety in everyday use.

At a glance

Status

Not yet recruiting

Phase

Phase IV

Sponsor

Spineart (Switzerland)

Enrolment target

118

Start

19 Oct 2026

Estimated completion

19 Oct 2027

Cervical radiculopathy and/or myelopathy, secondary to degenerative disc disease (DDD) and/or spondylosis at consecutive levels between C3 and C7

What is this study about?

You might be familiar with ongoing neck pain or arm pain, which can be really debilitating. Often, these issues stem from 'wear and tear' in the bones and discs of your neck, known as degenerative disc disease or spondylosis. When usual treatments like pain relief or physiotherapy aren't enough, doctors sometimes recommend surgery. A common operation is called an anterior cervical discectomy and fusion (ACDF).

In ACDF surgery, the surgeon removes the damaged disc in your neck and then uses a special implant to help the bones on either side of where the disc was to grow together, or 'fuse'. This fusion helps to stabilise the neck and relieve pressure on nerves. The SCARLET® AC-Ti device is one such implant that is already used in these types of operations.

This study is designed to carefully observe how well the SCARLET® AC-Ti device works and how safe it is for patients in real-world conditions. Researchers will closely follow patients who have this device implanted, checking things like whether their bones successfully fuse together, how their neck and arm pain changes, and how their day-to-day activities improve over time. The goal is to gather more information about how effective and safe this particular implant is when used in routine clinical practice.

Key takeaways

This study evaluates an implant (SCARLET® AC-Ti) used in neck fusion surgery.
It aims to understand how well the device works and its safety in real patients.
Participation involves your regular surgery, plus extra follow-up visits and questionnaires.
The study looks at bone fusion, pain levels, and overall recovery over two years.
You'll receive the same medical care whether you join or not, there are no additional medical benefits from taking part.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older who is already scheduled to have neck surgery using the SCARLET® AC-Ti device.

It's important that your neck or arm pain is due to common 'wear and tear' conditions in your neck discs or bones, and not from other causes. You also need to be willing and able to attend all the follow-up appointments, have imaging scans (like X-rays), and fill out questionnaires.

If you have any other serious medical conditions that might make it difficult to complete the study, or if you're unable to attend appointments over the two-year period, you might not be suitable for this study.

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 scheduled for neck fusion surgery using the SCARLET® AC-Ti device?
Is your neck or arm pain due to 'wear and tear' in your neck bones or discs?
Are you able and willing to attend follow-up appointments for about two years?
Are you able to complete questionnaires and have X-rays or scans when asked?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll undergo your planned neck surgery using the SCARLET® AC-Ti device, just as you would normally. Before your surgery, during your hospital stay, and at several follow-up visits, information will be collected. These follow-up visits will be scheduled between 4 and 12 weeks after surgery, and then again at around 6 months, 12 months, and 24 months (two years) after your operation. Each visit will involve medical assessments by your healthcare team, imaging scans like X-rays and potentially CT scans, and you'll be asked to complete questionnaires about your recovery, such as how your arm and neck pain is, and how it impacts your daily activities. There are no new medications involved in this study; it's purely about observing the outcomes of standard surgery.

Potential risks and benefits

Taking part in this study means you'll receive the same surgery and care whether you join or not; there are no additional medical benefits from participating in the study itself. The risks involved are those normally associated with neck surgery, and your participation in the study doesn't increase these surgical risks. You won't face any new risks from the extra visits or questionnaires. However, compared to standard follow-up, you might have a few more imaging scans, which means a small, additional exposure to a type of radiation called ionising radiation. Remember, you are always free to withdraw from the study at any time without affecting your medical treatment.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northumbria Healthcare NHS Foundation Trust
Unverified
Newcastle upon Tyne, England
Hôpital Henri-Mondor
Unverified
Créteil, France
Clinique des Cèdres
Unverified
Cornebarrieu, France
CHU Tivoli
Unverified
La Louvière, Belgium

Common questions

What is the SCARLET® AC-Ti device?

It's a special implant used in neck surgery to help the bones in your neck fuse together after a damaged disc is removed.

What kind of neck problems is this study for?

It's for neck pain or arm pain caused by common 'wear and tear' issues in the neck, like worn-out discs or joint changes.

Will I get different surgery if I join the study?

No, you will receive the exact same neck surgery and care as if you weren't in the study.

How long will I be followed in the study?

You'll be followed for about two years after your surgery, with several check-ups during that time.

Are there any extra risks if I participate?

The surgical risks are the same. You might have a few more X-rays or scans than usual, which means a very small extra amount of radiation exposure.

How to find out more

Dervilla Bermingham

clinic@spineart.com +33 (0)22 561 12 00 Official trial record

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