Surgical Treatment of Pelvis in Fragility Fracture in Germany: a Prospective, National, Multicenter, Observational, Comparative Cohort Study Comparing Isolated Posterior Versus Combined Anterior-posterior Surgical Fracture Stabilization (AO TOP)

AO Innovation Translation Center

Status

Not yet enrolling

Conditions

Pelvis; Fracture

Treatments

Procedure: Fracture stabilization

Study type

Observational

Funder types

Other

Identifiers

NCT06550934

AO TOP

Details and patient eligibility

About

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.

Enrollment

420 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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