Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT05367505
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2022-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Sponsor:
University of Witten/Herdecke
Organization:
Study Overview
Official Title:
Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Status:
RECRUITING
Status Verified Date:
2025-08
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:
TIKTIS
Brief Summary:
Many approaches to the surgical treatment of OF-P have been tried, but no one method has stood out as particularly successful. The placement of three implants, including implants that could minimise motion in the sacroiliac joint through early fixation and long-term fusion of the sacroiliac joint, can prevent micromotion in the fracture and thereby improve the clinical outcome of OF-Ps.
The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients.
The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.
The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients.
The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: