RecruitingOBSERVATIONAL

Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®

This study, called 'Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®', is investigating the Synergy cervical spine disc replacement. This device is used for people with cervical degenerative disc disease, which often causes neck pain due to worn-out discs in the neck. The study aims to understand how safe and effective the Synergy Disc system is in regular medical practice. It’s an observational study, meaning researchers will collect information about patients’ experiences rather than giving them a new treatment. They will look at patients who have already had the Synergy Disc implanted (retrospective group) and those who are scheduled to receive it (prospective group). This helps gather important information about how the device performs over time for different individuals.

At a glance

Status

Recruiting

Sponsor

Synergy Spine Solutions

Enrolment target

Start

17 Mar 2025

Estimated completion

01 Dec 2034

Cervical Degenerative Disc Disease

What is this study about?

This study is looking at a medical device called the Synergy Disc, which is a type of artificial disc used in the neck. It's designed for people who suffer from cervical degenerative disc disease. This condition happens when the discs cushioning the bones in your neck (your vertebrae) wear down, which can lead to pain, numbness, or weakness in the arms and neck because nerves get pinched. The Synergy Disc aims to replace a damaged disc, helping to restore movement and relieve symptoms.

The main goal of this research is to see how well the Synergy Disc works in real-life medical settings, outside of a strictly controlled clinical trial. Researchers want to understand both how safe the device is and how effective it is at helping patients with their symptoms. They are collecting information from hospitals that use this disc, specifically looking at patients who have already had it implanted (this is called the 'retrospective' group) and those who are planning to have it put in (the 'prospective' group).

By gathering data from both these groups, the study can get a comprehensive picture of the Synergy Disc’s performance. This kind of 'post-market' study is important because it helps medical professionals and regulatory bodies understand the long-term effects and benefits of new medical devices once they are being used more widely. It provides valuable insights that can help improve patient care in the future.

Key takeaways

This study evaluates an artificial neck disc called the Synergy Disc.
It aims to understand the device's safety and effectiveness in real-world use.
You must have had, or be planning to have, a Synergy Disc implanted.
Participation involves sharing your anonymised medical records; no extra procedures are required.
The study helps improve future care for patients with neck disc problems.
You can withdraw your consent at any time.

Who may be eligible?

To be considered for this study, you would need to be at least 21 years old. You must have already had, or be scheduled to have, a Synergy Disc implanted in your neck. This surgery should be to replace a disc between the C3 and C7 vertebrae (bones in your neck) because of ongoing pain, numbness, or weakness in your arm or neck. This condition is often caused by a slipped disc or bone spurs pressing on nerves or the spinal cord.

Before considering surgery, your symptoms should have persisted for at least six weeks despite trying other treatments, such as physical therapy or medication. Medical scans like MRI or CT scans must also clearly show that a disc problem is causing your symptoms. Finally, you would need to give your written permission to take part in the study.

There are several reasons why you might not be able to participate. For example, if you have severe arthritis in your neck, very weak bones (like osteoporosis or osteopenia), or an active infection. Pregnant individuals, those with significant instability in their neck, or other serious neck conditions beyond the disc disease itself would also not be eligible. If you've had other spine surgeries that have made parts of your neck immobile, or if you are very overweight, you would also be excluded.

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 21 years old or older?
Have you had, or are you going to have, a Synergy Disc implanted in your neck?
Are your neck or arm symptoms caused by a disc problem (herniated disc or bone spur) confirmed by scans?
Have your symptoms lasted at least 6 weeks despite other treatments?
Do you not have severe osteoporosis, severe neck arthritis, or an active infection?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means you won't be given any experimental treatments. If you're part of the 'prospective' group (meaning you're about to have the surgery), researchers will collect information before your operation and then follow your progress afterwards. If you're in the 'retrospective' group (you've already had the surgery), researchers will look back at your existing medical records. The study will not involve any additional visits or assessments beyond what would normally be part of your standard medical care and follow-up after your disc replacement surgery. There are no new medications involved and the total duration would depend on how long your medical records are reviewed or how long your standard follow-up care lasts. You would not need to do anything extra as part of this study.

Potential risks and benefits

Taking part in this study primarily involves the collection of your health information from your medical records; therefore, there are no direct medical risks directly from the study itself beyond the risks associated with the surgery you are undergoing as part of your normal treatment. You will not receive any experimental treatments. The potential benefit is that data from your experience could help medical professionals better understand the Synergy Disc and improve care for future patients. You have the right to withdraw your consent to participate at any time without it affecting your medical care.

Locations (2)

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

Royal Orthopaedic Hospital
Verified postcode
Birmingham, United Kingdom· Recruiting
Kings College Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the Synergy Disc?

It's an artificial disc replacement device used in the neck to help people with worn-out spinal discs.

Why is this study being done?

The study aims to understand how safe and effective the Synergy Disc is in real patients, after it has been approved for use.

Do I have to do anything extra if I join?

No, this is an observational study. Researchers will use your existing medical information, so you won't need extra visits or treatments.

What is 'cervical degenerative disc disease'?

This is a condition where the discs in your neck wear down, which can lead to neck or arm pain, numbness, or weakness.

Can I still withdraw from the study?

Yes, you can choose to stop participating at any time without it affecting your medical care.

How to find out more

Robyn Capobianco, PhD

rcapobianco@synergyspinesolutions.com (720) 787-9063 Official trial record

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