Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-26 @ 7:59 PM
Study NCT ID:
NCT05916092
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-06
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Study on a Modular SI Joint Fusion System
Sponsor:
CornerLoc
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Post Market Surveillance Study on a Modular SI Joint Fusion System
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
SPARTAN
Brief Summary:
A prospective study on the use of the TransLoc 3D SI Joint Fusion System for patients with sacroiliac joint disruptions or degenerative sacroiliitis.
Detailed Description:
Multicenter, prospective, post-market surveillance study on the TransLoc 3D Sacroiliac Joint Fusion System including two treatment arms: 1) Lateral-Oblique TransLoc 3D Screw(s), 2) Lateral Oblique TransLoc 3D Screw with Posterior Device (Hybrid). Data from this post-market study will be used to support knowledge of clinical efficacy and improvement with the use of TransLoc 3D Sacroiliac Joint Fusion System.
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?: