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.
Are You a Potential Candidate for the Trial?
You have arm/hand/shoulder pain and/or neurological symptoms such as numbness or weakness with or without neck pain.
You have tried at least 6 weeks of nonsurgical care such as physical therapy or medication, or have symptoms that are getting progressively worse.
A physician has indicated that you may need neck surgery to treat your symptoms.
You are willing to undergo spine surgery.
(This is a Surgical Procedure)
You have not had any previous surgeries on your neck (fusion, laminectomy, discectomy, etc.).
Why Participate in the SMART Clinical Study?
Potential access to implants that provide surgeons with options to better fit a patient’s anatomy
Potential access to proven implants not currently available in the US
Receive enhanced medical oversight and focus from your surgeon and study staff
Frequently Asked Questions
Upon reviewing your MRI, CT scan, and/or X-rays, your surgeon may diagnose you with 2-level symptomatic cervical disc disease, and recommend surgery to relieve your symptoms. After assessing these factors and others that are required according to the FDA study criteria (e.g., two-level indication, no prior fusion or disc replacement surgery, etc.), the surgeon will consult with you and help you to decide if you want to participate in the study.
If you qualify for the study and decide to participate, you will be randomly assigned by the computer to one of the two treatments groups (Investigational [prodisc C devices] or Control [the Mobi-C device]). The randomization is 2:1, such that for every 1 patient assigned to the Control, 2 patients are assigned to the Investigational. Your treatment assignment is generated by a computer. You will not know your randomization until after surgery.
Yes. prodisc C Vivo is the most widely used total disc replacement (TDR) device outside the US and its clinical benefits have been documented through actual use since 2009. prodisc C SK is a modification of the FDA-approved prodisc C product that has been used in the US since 2007. The control device, Mobi-C, was FDA-approved in 2013 and is the most widely used TDR in the US.
The study visits post-surgery are similar to the standard of care visits typical for this type of surgery. You will be evaluated at follow-up visits that occur at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 18 months (phone call), and 24 months. After the 24 month visit, you will be seen annually for an additional 5 years. You may receive compensation for completion of each follow-up study visit. When you agree to be in a study, the expectation is that you will remain in the study for all of the follow-up visits. You can stop participating at any time without affecting your regular medical care. If you choose to discontinue, you should discuss with your physician, their recommendations for follow-up care.
Before participating in a study, patients are provided with information about the study and 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.
During the Informed Consent process, the Informed Consent document is provided to the patient. The Informed Consent document includes details about the study, including how long the study will last, the 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.
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, the Physician and research staff under federal guidelines to “protect the rights and welfare of research subjects.”
Your rights include:
All the anonymized patient data collected 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.