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).
The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
390
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).
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).
Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C)
Includes assessments such as NDI and neurological improvement.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 20 more locations