MedTrace Logo

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

NCT05367505 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Pelvic Fracture
  • Insufficiency Fractures
  • Mobility 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.

Sponsors & Collaborators

  • SI-BONE, Inc.

    collaborator INDUSTRY

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • University of Witten/Herdecke

    lead OTHER

Principal Investigators

  • Erol Gercek, Prof. · University Medical Center of the Johannes Gutenberg University Mainz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05367505 on ClinicalTrials.gov