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

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.

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.