Status:
RECRUITING
Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Lead Sponsor:
University of Witten/Herdecke
Collaborating Sponsors:
SI-BONE, Inc.
Johannes Gutenberg University Mainz
Conditions:
Pelvic Fracture
Insufficiency Fractures
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05367505
Start Date
January 9 2023
End Date
December 1 2026
Last Update
August 11 2025
Active Locations (3)
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1
Diakonie Krankenhaus
Bad Kreuznach, Germany, 55543
2
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Germany, 55131
3
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42283