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).
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).
| Facility | City | Region | Status |
|---|---|---|---|
| Flagstaff Bone and Joint | Flagstaff | Arizona | |
| Todd Lanman, MD, Inc. | Beverly Hills | California | |
| Doctors Outpatient Center for Surgery | Los Angeles | California | |
| Sutter Health - Palo Alto Medical Foundation | Palo Alto | California | |
| Sutter Health | Sacramento | California | |
| HCA Healthcare | Lone Tree | Colorado | |
| Sky Ridge Medical Center Campus | Lone Tree | Colorado | |
| Center for Spine and Orthopedics, Scientific Education and Research Foundation | Thornton | Colorado | |
| Georgetown University Hospital | Washington D.C. | District of Columbia | |
| St. Vincent's Neurosurgery | Jacksonville | Florida | |
| Kennedy-White Orthopaedic Center | Sarasota | Florida | |
| University of South Florida | Tampa | Florida | |
| Florida Orthopaedic Institute | Temple Terrace | Florida | |
| Indiana Spine Group | Carmel | Indiana | |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | |
| Spine Institute of Louisiana | Shreveport | Louisiana | |
| University of Maryland Medical Center | Baltimore | Maryland | |
| William Beaumont Hospital | Royal Oak | Michigan | |
| University Spine Center | Wayne | New Jersey | |
| NYU Langone Orthopedic Hospital | New York | New York | |
| Hospital for Special Surgery | New York | New York | |
| Northwell Health, Lenox Hill Hospital | New York | New York | |
| Axis Neurosurgery and Spine | Williamsville | New York | |
| M3-Emerging Medical Resarch | Durham | North Carolina | |
| SVCMC Solon Medical - Northern Ohio Surgery Center | Beachwood | Ohio | |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | |
| DFW Center for Spinal Disorders | Fort Worth | Texas | |
| Texas Back Institute | Plano | Texas | |
| Texas Spine Care Center | San Antonio | Texas | |
| The Disc Replacement Center | Salt Lake City | Utah |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04012996 on ClinicalTrials.gov ↗ ← All trials in the USA