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RECRUITING
NCT05367505
NA

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

Sponsor: University of Witten/Herdecke

View on ClinicalTrials.gov

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.

Official title: Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-01-09

Completion Date

2026-12-01

Last Updated

2025-08-11

Healthy Volunteers

No

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.

Locations (3)

Diakonie Krankenhaus

Bad Kreuznach, Germany

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Germany

Helios Universitätsklinikum Wuppertal

Wuppertal, Germany