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

Join our study on the M6-C® cervical disc for neck health!

Recruiting
18-75 years
All
Phase N/A

The study is exploring the safety and effectiveness of a specific artificial cervical disc called the M6-C™, compared to a traditional surgery called ACDF (Anterior Cervical Discectomy and Fusion). The focus is on patients with neck problems, known as cervical radiculopathy, which causes pain or discomfort due to nerve or spinal cord pressure. Participants will have either the M6-C disc inserted or undergo ACDF, based on their group assignment. The study will track patient progress over two years, with evaluations at different times to measure success.

  • Duration: 24 months with regular check-ups.
  • Eligibility: Must be 18-75 years old, with specific neck issues, and able to attend follow-ups.
  • Risks: Potential risks associated with surgery will be discussed with participants.

Interested individuals should have tried non-surgical treatments for at least six weeks without success. Certain conditions like severe bone diseases, previous neck surgeries, or being pregnant may disqualify participation. Participants will sign a consent form and adhere to study requirements.

Study details
    Cervical Disc Degenerative Disorder

NCT04982835

Spinal Kinetics

10 October 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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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.

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

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

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