Clinical Trial

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

Study acronym: AO TOP
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-09; most recent amendment 2025-02-13.
Trial Details
NCT Number NCT06550934
Lead Sponsor AO Innovation Translation Center
Collaborators: AUC - Akademie der Unfallchirurgie, AO Trauma Deutschland e.V.
Conditions Pelvis; Fracture
Enrollment 420 participants
Start Date 2025-03
Primary Completion 2026-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2025-02-14