The SMART 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 two investigational devices, the prodisc® C SK and prodisc® C Vivo compared to the Mobi-C® Cervical Total Disc Replacement.
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)?
To contact the participating surgeon(s) near you to determine if you may be a candidate for the study, please click the buttons below.
Investigators:
Todd Lanman, MD
Jason Cuellar, MD
Office Locations:
Beverly Hills, CA
San Pedro, CA
Investigators:
Brian Perri, MD
Neel Anand, MD
Patrick Hill, MD
Edward Nomoto, MD
Khawar Siddique, MD
Albert Wong, MD
Office Location:
Los Angeles, CA
CONTACT THE STUDY COORDINATORSInvestigator:
Alexandre Rasouli, MD
Office Location:
Los Angeles, CA
CONTACT THE STUDY COORDINATORSFor more information, visit ClinicalTrials.gov (Identifier NCT04012996).
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
Available in U.S. |
Since 2007 |
Investigational Device
Available Outside U.S. |
Since 2009 |
Mobi-CAvailable 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:
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.
What should I expect?
Before participating in a study, patients are provided with information about the study and are given the chance to ask questions. This process is called Informed Consent. The purpose of the informed consent process is to make sure patients are adequately informed of important details about the clinical study so they can make an informed choice about their participation. Informed Consent begins before a research volunteer agrees to participate in a trial and continues throughout the study.
The Informed Consent document describes the study to research patients. It includes details about the study’s purpose, length, procedures, risks and benefits, and other information that all patients should know. Patients sign the document before they enter the study, but only after having read and discussed it with the research team and demonstrating an understanding of the information provided. In some cases, there will be multiple Informed Consent documents throughout the study as changes are made to the study protocol or new safety information becomes available. Signing the document(s) and providing consent is not a contract. Patients may withdraw from a study at any time, even if the study is not over.
The SMART Study has been reviewed and approved by the FDA. Hospitals and physicians won’t participate until their institutional review board (IRB) has thoroughly reviewed the study protocol and approved it. It is the responsibility of the IRB under federal guidelines to “protect the rights and welfare of research subjects.”
Your rights include:
All anonymized patient data will be analyzed and submitted to the FDA for review. If the clinical trial is approved, the prodisc C SK and prodisc C Vivo can become available to other surgeons and patients in the U.S. Additionally, the results will be publicly shared on ClinicalTrials.gov, and in appropriate medical journals and with qualified medical professionals.
