Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 9, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2026

Conditions
Pelvic FractureInsufficiency FracturesMobility Limitation
Interventions
DEVICE

iFuse-3D implant

The iFuse Implant System consists of cannulated triangular titanium implants (Ti 6AI4V ELI, ASTM F136) with a porous coating of commercially pure titanium plasma spray (C.P. Ti, ASTM F1580) and a setting instrument. The coating and special shape of the implants prevent rotation or displacement of the sacroiliac (SI) joint. The placement instrument uses guide pins to achieve precise placement.

Trial Locations (3)

42283

RECRUITING

Helios Universitätsklinikum Wuppertal, Wuppertal

55131

NOT_YET_RECRUITING

University Medical Center of the Johannes Gutenberg University Mainz, Mainz

55543

RECRUITING

Diakonie Krankenhaus, Bad Kreuznach

All Listed Sponsors
collaborator

SI-BONE, Inc.

INDUSTRY

collaborator

Johannes Gutenberg University Mainz

OTHER

lead

University of Witten/Herdecke

OTHER