SMART™ clinical study

What is the
SMART™ clinical study?

The SMART Study (Select Match Artificial Disc Replacement Two-level Study) is a nationwide clinical trial investigating the treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD). The purpose of the trial is to evaluate the safety and effectiveness of prodisc® C SK and prodisc® C Vivo compared to the Mobi-C® Cervical Disc.


Why Participate in the SMART Clinical Study?


1

Potential access to spinal implants not currently available in the US

2

Benefit future United States patients by validating the safety and effectiveness of advancements in cervical total disc replacement technology

3

Receive post-operative study-related care

The primary purpose of the SMART study is to show that the prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis (Mobi-C) to treat symptomatic cervical disc disease (SCDD) in patients at two contiguous levels from C3 to C7.

The Mobi-C is the most widely used total disc replacement (TDR) in the US.

The prodisc C Vivo is the most widely used TDR outside the US, while the prodisc C SK is a modification of the currently US-approved prodisc C.

Available in U.S.

Since

2007

Investigational Device

Available Outside U.S.

Since

2009

Mobi-C

Available in U.S.

Since

2013

Investigational Device

Under Study

Studied in

2019


What is a clinical trial?


Clinical trials are scientific studies conducted to find new therapies.

The SMART Study assesses results between two different total disc replacement technologies. Both device types are composed of three components:

  1. A superior endplate (top component) that provides immediate stability with a porous titanium coating to enable bone to grow onto over time. The endplate provides a smoooth interior surface for articulation over the plastic component (#2).
  2. A medical grade polyethylene (plastic) core that acts as an articulating surface between the other two components.
  3. An inferior endplate (bottom component) that provides immediate stability with a porous titanium coating to enable bone to grow onto over time. The polyethylene core is locked into the inferior endplate.

The prodisc C Vivo and the prodisc C SK are different from each other in that the bone facing surfaces have different shapes and stabilizing features to accommodate differing patient anatomy.


What should I know about my participation?


Every clinical trial has a protocol that must be followed. The protocol outlines how to conduct the trial and the eligibility criteria for patient selection. Using standardized eligibility criteria (inclusion and exclusion criteria) helps the researchers understand that the results are due to the treatment. Participation in the SMART Study requires commitment to return to your physician for follow-up visits.

Your trial visits are different than a regular clinical visit. For instance, you will meet with the research team at each visit. When you agree to be in a trial, the expectation is that you will remain in the study for all of the follow-up visits.


Please Note:
You may have extra procedures, questionnaires or visits. You can stop participating at any time without affecting your regular medical care. You may receive a stipend for study-related expenses.

Am I a Potential Candidate for the Trial?

To determine if you meet common eligibility criteria for the clinical trial, click the button below to answer one to three questions. If you meet these common criteria, please contact a site near you to further discuss the inclusion and exclusion criteria, as well as any additional protocol requirements.

SEE IF I AM ELIGIBLE  

Question:
Do you have arm pain and/or neurological symptoms such as numbness or weakness with or without neck pain?

No, I do not.   Yes, I do.  

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