What is the
SMART™ Total Disc Replacement
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.
Am I a Potential Candidate for the Trial?
Listed below are some questions to help you determine whether your condition makes you a potential candidate for the study:
Do you have arm pain and/or neurological symptoms such as numbness or weakness with or without neck pain?
Have you tried at least 6 weeks of nonsurgical care such as physical therapy or medication, or have symptoms that are getting progressively worse?
Has a physician indicated that you may need surgery in your cervical spine (neck)?
Why Participate in the SMART Clinical Study?
Potential access to spinal implants not currently available in the US
Benefit future United States patients by validating the safety and effectiveness of advancements in cervical total disc replacement technology
Receive post-operative study-related care
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:
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.
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.