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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT06550934
Eligibility Criteria:
Inclusion Criteria:
* Patients with sacral FFP (no concomitant injuries) Types: IIc, IIIc, IVb, IVc according to Rommens and Hofmann associated with fracture of the anterior pelvic ring (fractures involving the anterior lip of the acetabulum that are not regarded as acetabular fracture will be included)
* Diagnostic workup for fracture diagnosis and classification performed using CT scan as per standard of care
* Indication for surgical fracture fixation as considered by the attending surgeon
* Age ≥ 65 yrs.
* Low-energy trauma fracture, or osteoporotic fracture, or insufficiency fracture, or spontaneous fracture
* ASA-Score ≤ 3 pts.
* Ability to provide informed consent according to the IRB/EC defined and approved procedures
Exclusion Criteria:
* Patients with multiple fractures
* Instability of the pubic symphysis (ie, visibility of a widening or diastasis of the symphysis), and/or fractures of the pubic rami next to the symphysis, that indicate instability
* Pelvic fractures due to high-energy trauma
* Pathologic fractures (eg, fractures caused by malignancy or infection)
* History of pelvic fracture or pelvic ring surgery (hip joint implants do not count)
* Clinically significant or unstable medical or surgical condition that prevents surgical treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06550934
Study Brief:
Protocol Section:
NCT06550934