RecruitingNot ApplicableNCT05367505

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

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

Sponsor

University of Witten/Herdecke

Enrollment

60 participants

Start Date

Jan 9, 2023

Study Type

INTERVENTIONAL

Conditions

Mobility Limitation Pelvic Fracture Insufficiency Fractures

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.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical implant system that uses titanium fusion with trans-iliac screws to stabilize pelvic fractures in elderly patients with osteoporosis-related (fragility) fractures of the pelvis. Researchers want to know if this procedure reduces pain and restores mobility faster than current treatments. **You may be eligible if...** - You are 60 or older - You have an acute or recent (within 2 months) pelvic fracture from a low-energy injury or spontaneously - Your fracture is a specific type (OF3 or OF4 classification) confirmed by CT or MRI - You were mobile (not wheelchair-bound) before the fracture **You may NOT be eligible if...** - You have severe, uncontrolled psychiatric illness (such as dementia or schizophrenia) - You had a previous pelvic fracture within the last year - You were unable to walk before the fracture - You have had extensive prior spinal surgery involving more than two vertebrae - Your fracture is related to a tumor in the pelvis - You have a known allergy to titanium - You are currently participating in another interventional trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEiFuse-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.