The SMART™ Total Disc Replacement
Is this right for you?
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.