Centinel Spine Clinical Study for Total Disk Replacement for 2-Level Symptomatic Cervical Disk Disease

Florida Orthopaedic Institute is one of multiple study sites in the Centinel Spine, LLC, Multicenter, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of prodisc® C SK and prodisc® C Vivo to the Mobi-C® Cervical Disk in the Treatment of Two-Level Symptomatic Cervical Disk Disease (SCDD).

The prodisc products being used in the trial are built on the prodisc technology platform, the most widely used Total Disk Replacement system in the world. No other disk replacement system has been studied more—with over 13,000 patients reported on in more than 540 articles throughout a global clinical usage period of 30+ years. The prodisc technology has been validated with almost 225,000 device implantations and a reported reoperation rate of less than 1%. The prodisc C Vivo has been used outside the US for over 10 years, and the prodisc C SK device is an evolution of the original prodisc C, with a smaller keel design.

The Mobi-C (Zimmer Biomet) is FDA-approved for 1- and 2-level use. The prodisc systems are being investigated for approval by the FDA for 2-Level use.

Enrolled patients will be evaluated before surgery, as well as after surgery (2 and 6 weeks, 3-, 6-, 12- and 24 months)—with each visit taking approximately 1-2 hours. After the 2-year visit, patients return annually for follow-up visits for 5 years. Approximately 20 patients will be included in the study at Florida Orthopaedic Institute, with a minimum of 390 in the study overall. Patients with appropriate indications should review their condition with their doctor to determine if involvement in the clinical trial is appropriate.

ARE YOU A POTENTIAL CANDIDATE FOR THE TRIAL?

Potential participation in the trial would consider the following factors:

• You have arm/hand/shoulder pain or neurological symptoms such as numbness or weakness with or without neck pain.
• You have tried at least six 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 a previous fusion or total disk replacement surgery on your neck.

PARTICIPATING SURGEONS:

• Brooks R. Osburn, MD
• Adil Samad, MD
• John Small, MD
• Steven Tresser, MD

CONNECT WITH OUR RESEARCH TEAM TO SEE IF YOU QUALIFY TO PARTICIPATE OR ASK YOUR DOCTOR AT YOUR NEXT APPOINTMENT.

If you are interested in participating in this study, you can email the study team at:
ClinicalResearch@FOREonline.org and put “Centinel Spine” in the subject line.

You can also call or email the research coordinator directly:

Debbi Warren
dwarren@foreonline.org
813-978-9700, x 6766

For more information about the clinical trial, including inclusion/exclusion criteria, please visit https://clinicaltrials.gov/ct2/show/NCT04012996