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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
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Start date: Jan 2025 to Mar 2025
    • Collaborators reordered
    v3
  2. Notable Start date: Oct 2024 to Jan 2025
    • Eligibility criteria shortened, about 23 words
    • Study title expanded, about 16 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06550934
Lead Sponsor AO Innovation Translation Center
Collaborators: AUC - Akademie der Unfallchirurgie, AO Trauma Deutschland e.V.
Conditions
(from sponsor)
Pelvis; Fracture
Related terms Hip Fractures
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov