Fragility fractures of the pelvis FFP type IIc or higher according to Rommens and Hofmann
Conditions
Interventions
Group 1: Patients over 65 years of age with exclusively posterior surgical fixation after fragility fracture of the pelvis (FFP) according to the standard of care of the participating study centre wil
Sponsors
AO Trauma Deutschland
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale (NRS) of pelvic related pain 3 months after surgical fixation of the fragility fracture of the pelvis | — |
Secondary
| Measure | Time frame |
|---|---|
| • To analyze the differences in clinical, clinician- and patientreported outcomes between isolated posterior and combined anterior-posterior surgical fixation • To analyze the effect of different fracture types (according to the Rommens and Hofmann classification) on the different outcome parameters in patients treated with isolated anterior surgical fixation compared to patients treated with a combined anteriorposterior surgical fixation • Comparison of the adverse event (AE) rates, morbidity and mortality between isolated posterior vs combined anteriorposterior surgical fixation and, if numbers allow, between different surgical techniques within the two treatment groups • To investigate the impact of demographical and medical history data, as well as injury and fracture details on the outcome within the two treatment groups • To analyze the impact of different surgical techniques and stabilization devices on the different outcome parameters in patients treated with isolated anterior compared to patients treated with a combined anterior-posterior surgical fixation • To analyze regional differences in fracture patterns, patient cohorts and resulting surgical approaches. | — |
Countries
Germany
Contacts
Public ContactRichard Stange
AO Trauma Deutschland
Outcome results
None listed