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2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Sponsor: Centinel Spine
Summary
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
Official title: A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)
Key Details
Gender
All
Age Range
18 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2019-08-05
Completion Date
2028-05-13
Last Updated
2025-07-30
Healthy Volunteers
Yes
Conditions
Interventions
prodisc C SK and/or Vivo
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Mobi-C Cervical Disc
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Locations (30)
Flagstaff Bone and Joint
Flagstaff, Arizona, United States
Todd Lanman, MD, Inc.
Beverly Hills, California, United States
Doctors Outpatient Center for Surgery
Los Angeles, California, United States
Sutter Health - Palo Alto Medical Foundation
Palo Alto, California, United States
Sutter Health
Sacramento, California, United States
HCA Healthcare
Lone Tree, Colorado, United States
Sky Ridge Medical Center Campus
Lone Tree, Colorado, United States
Center for Spine and Orthopedics, Scientific Education and Research Foundation
Thornton, Colorado, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
St. Vincent's Neurosurgery
Jacksonville, Florida, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Florida Orthopaedic Institute
Temple Terrace, Florida, United States
Indiana Spine Group
Carmel, Indiana, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
University Spine Center
Wayne, New Jersey, United States
NYU Langone Orthopedic Hospital
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Northwell Health, Lenox Hill Hospital
New York, New York, United States
Axis Neurosurgery and Spine
Williamsville, New York, United States
M3-Emerging Medical Resarch
Durham, North Carolina, United States
SVCMC Solon Medical - Northern Ohio Surgery Center
Beachwood, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
DFW Center for Spinal Disorders
Fort Worth, Texas, United States
Texas Back Institute
Plano, Texas, United States
Texas Spine Care Center
San Antonio, Texas, United States
The Disc Replacement Center
Salt Lake City, Utah, United States