Clinical Trial

2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C

Study acronym: SMART
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 30, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2019-07-05; most recent amendment 2025-07-28.
Status change: Recruiting → Active, Not Recruiting 2025-07-28
Status change: Not Yet Recruiting → Recruiting 2019-08-07
Trial Details
NCT Number NCT04012996
Lead Sponsor Centinel Spine
Conditions Symptomatic Cervical Disc Disease
Enrollment 390 participants
Start Date 2019-08-05
Primary Completion 2025-08-31 (estimated)
Study Completion 2028-05-13 (estimated)
Updated on ClinicalTrials.gov 2025-07-30