About this trial
Over a period of approximately two years, patients above the age of 65 who have suffered from an FFP equal to or higher than type IIc FFP, according to Rommens and Hofmann, will be eligible for inclusion. At least 420 patients will be included and followed up up for 12 months. Treatment and postoperative care, will be as per standard of care at the participating institution, with a free choice of isolated posterior or combined anterior-posterior surgical treatment.
Pain levels, quality of life, level of mobility and independence will be assessed at different time points. Furthermore, both clinical and radiographic outcomes, complications, morbidity and mortality associated with interventions will be evaluated. Assessment and evaluation will be performed at defined time points during FU according to standard of care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
Patients 65 years or older with a fragility fracture in the pelvis.
Trial design
Cohort
Prospective
Treatments tested in this trial
Fracture stabilization
Procedure/Surgeryisolated posterior surgical fracture stabilization vs. combined anterior-posterior surgical fracture stabilization
Treatment groups
Trial outcomes
Primary outcomes
Pain rating
Perception of pain will be assessed using Numeric Rating Scale (NRS) from 1-10, where patient reports pain due to his/her pelvis fracture. A higher value correlates with greater pain.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
AO Innovation Translation Center
Lead sponsor
AUC - Akademie der Unfallchirurgie
Collaborator
AO Trauma Deutschland e.V.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: