Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07370493
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-27
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
Sponsor:
Centinel Spine
Organization:
Study Overview
Official Title:
A Multicenter, Retrospective Analysis to Evaluate Radiographic Outcomes and Safety Profiles Along Prospective Follow-Up Periods for Patients Implanted With 2 Levels of Prodisc® C Vivo Devices.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-01
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:
None
Brief Summary:
The objective of the study is to evaluate the safety and post-operative performance profile of the prodisc® C Vivo after implantation in comparison to the relevant clinical literature.
Detailed Description:
The primary objective of the study is to evaluate (estimate) the post-operative performance of prodisc® C Vivo overall, after implantation. Post-operative device performance will be estimated using Patient Reported Outcomes (PROs) and radiographic data derived from the patient's surgical charts and medical history.
The secondary objectives of this study are to assess:
* patients with no secondary surgical interventions (SSIs), i.e. revision, removal, re-operation, supplemental fixation at the index level(s)
* the rates of ADEs inclusive of intraoperative and post-operative complications
* Patient Reported Outcomes (PROs)
* Outcome self-assessment of Health Survey (SF 12 or 36 as available)
The secondary objectives of this study are to assess:
* patients with no secondary surgical interventions (SSIs), i.e. revision, removal, re-operation, supplemental fixation at the index level(s)
* the rates of ADEs inclusive of intraoperative and post-operative complications
* Patient Reported Outcomes (PROs)
* Outcome self-assessment of Health Survey (SF 12 or 36 as available)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: