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.
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.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Legal capacity, capacity to inform
* Presence of a written declaration of consent by the patient
* Age: ≥ 60 years
* Acute or subacute (less than 2 months) posterior pelvic girdle pain associated with low energy trauma or occurring spontaneously
* Diagnosis confirmed by CT and/or MRI
* The fracture corresponds to types OF3 and OF4 of the OF Pelvis classification.
* Prior to the fracture, there was free, non-wheelchair mobility (Functional Mobility Score of 2 or higher)
Exclusion Criteria:
* Diagnosed uncontrolled psychiatric illness (e.g. dementia, schizophrenia, major depression, personality disorder) that could affect study participation or reporting of findings
* History of pelvic fracture within one year with evidence of failure of fracture to heal or internal fixation of the pelvic ring of any type
* Patients unable to ambulate before the fracture
* Patient has had lumbar instrumentation of more than two vertebrae and/or instrumentation of S1 in the past
* Additional fractures that limit mobility
* OF-P associated with benign or malignant tumours of the pelvis
* Abnormal neurological condition that could affect study participation
* An unusual clinical condition associated with a high risk of not being able to follow up (e.g. COPD, severe heart failure, Parkinson's disease, autoimmune diseases)
* Any pelvic condition or anatomical feature that makes surgery impracticable
* Known allergy to titanium or titanium alloys
* Known opioid abuse for chronic pain syndromes
* Participation in other interventional trials
* Lack of surgical capability
* Persons in a dependent/employee relationship with the sponsor or investigator
* Placement in an institution due to court or administrative order.
Primary outcome measure(s)
Proportion of patients who regain their pre-fracture mobility as measured by the FMS by the time of hospital discharge — Time 8 days (discharge) after surgery The proportion is shown with frequencies and corresponding percentages.
Trial sites (3)
Facility
City
Region
Status
Diakonie Krankenhaus
Bad Kreuznach
Germany
University Medical Center of the Johannes Gutenberg University Mainz
Mainz
Germany
Helios Universitätsklinikum Wuppertal
Wuppertal
Germany
More University of Witten/Herdecke trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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