Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT05367505
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05367505
Study Brief:
Protocol Section:
NCT05367505