Ignite Creation Date:
2024-05-06 @ 1:25 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04012996
Status:
RECRUITING
Last Update Posted:
2022-10-28
First Post:
2019-07-05
Brief Title:
2-level Cervical Disc Replacement Comparing Prodisc C SK Vivo to Mobi-C
Sponsor:
Centinel Spine
Organization:
Centinel Spine
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART
Brief 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
Detailed Description:
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 21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None