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NCT Number: NCT06550934

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fracture stabilization

Procedure

isolated posterior surgical fracture stabilization vs. combined anterior-posterior surgical fracture stabilization

Primary outcomes

  1. Pain rating

    Time frame: Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Sob, PhD

CONTACT

[email protected]

+41798937428

Sponsors and collaborators

Lead sponsor

AO Innovation Translation Center

Other

Collaborators

  • AO Trauma Deutschland e.V.
  • AUC - Akademie der Unfallchirurgie

Registry information

Acronym: AO TOP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 13, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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