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M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study

Join our study on a new artificial cervical disc for neck issues!

Recruiting
18-75 years
All
Phase N/A

This study looks at a new device called the M6-C™ artificial cervical disc for people with neck and arm pain due to a problem called cervical radiculopathy. This is when nerves in the neck get squeezed, causing pain. The study compares this new disc to an old surgery method called ACDF (anterior cervical discectomy and fusion). In ACDF, doctors remove the damaged disc and fuse the bones together. In the study, some patients will get the M6-C disc, while others will have ACDF.

Participants must have tried regular treatments for at least six weeks without success. The study includes 263 patients who will be checked up on at 6 weeks, 3 months, 6 months, 12 months, and 24 months to see how well they are doing.

  • Study lasts for 2 years with several follow-up visits.
  • Participants should be between 18-75 years old.
  • Must not have more than two levels of neck problems needing surgery.
Study details
    Cervical Disc Degenerative Disorder

NCT04982835

Spinal Kinetics

10 October 2024

Step 1 Get in touch with the nearest study center
Entire USA
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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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