SMART™ clinical study

the SMART™ clinical study
Is this right for you?

Available Clinical Study Sites in the U.S.

The two-level prodisc C Vivo & prodisc C SK clinical study has expanded to multiple sites, each actively enrolling patients in the FDA monitored study. For more information, visit ClinicalTrials.gov (Identifier NCT04012996).


Arizona

Flagstaff, AZ

  • Principal Investigator: John Hall, MD
  • Website

California

Beverly Hills, CA

  • Principal Investigator: Todd Lanman, MD
  • Website

Los Angeles, CA

  • Principal Investigator: Brian Perri, MD
  • Website

Los Angeles, CA

  • Principal Investigator: Alexandre Rasouli, MD
  • Website

Colorado

Thornton, CO

  • Principal Investigator: Michael E. Janssen, DO
  • Website

Florida

Sarasota, FL

  • Principal Investigator: Ashvin Patel, MD
  • Website

Temple Terrace, FL

  • Principal Investigator: John Small, MD
  • Website

Kentucky

Paducah, KY

  • Principal Investigator: Kenneth Strenge, MD
  • Website

Louisiana

Shreveport, LA

  • Principal Investigator: Pierce Nunley, MD
  • Website

Maryland

Baltimore, MD

  • Principal Investigator: Daniel Gelb, MD
  • Website

Michigan

Royal Oak, MI

  • Principal Investigator: Jad Khalil, MD
  • Website

New Jersey

Wayne, NJ

  • Principal Investigator: Michael Faloon, MD
  • Website

New York

New York, NY

  • Principal Investigator: Aaron J. Buckland, MD
  • Website

North Carolina

Durham, NC

  • Principal Investigator: David Benjamin Musante, MD
  • Website

Ohio

Solon, OH

  • Principal Investigator: Robert McLain, MD
  • Website

Texas

Fort Worth, TX

  • Principal Investigator: Jason Tinley, MD
  • Website

Plano, TX

  • Principal Investigator: Jessica Shellock, MD
  • Website

Utah

Salt Lake City, UT

  • Principal Investigator: Armen Khachatryan, MD
  • Website

Washington, D.C.

Washington, D.C.

  • Principal Investigator: Faheem Sandhu, MD
  • Website
 

What should I expect?


What happens before the trial?

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.

How am I protected during the trial?

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:

  1. Ability to ask your physician or Centinel Spine about the study at any time.
  2. Privacy/confidentiality – your research records will be handled as confidentially as is possible within the law.
  3. Ability to withdraw your consent to participate in the study without penalty or loss of benefits at any time.
  4. Compensation for participation will be provided for your time. The ‘informed consent’ document outlines the details of this compensation.
  5. You will be informed of any new risks or findings during the course of the study.

What happens when the trial is over?

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.

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