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

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.

NCT Number	NCT05367505
Lead Sponsor	University of Witten/Herdecke Collaborators: SI-BONE, Inc., Johannes Gutenberg University Mainz
Conditions	Pelvic Fracture, Insufficiency Fractures, Mobility Limitation
Enrollment	50 participants
Start Date	2023-01-09
Primary Completion	2027-06-07 (estimated)
Study Completion	2028-02-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-23