Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
AO Innovation Translation Center
Collaborating Sponsors:
AUC - Akademie der Unfallchirurgie
AO Trauma Deutschland e.V.
Conditions:
Pelvis; Fracture
Eligibility:
All Genders
65+ years
Brief 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 inclus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06550934
Start Date
March 1 2025
End Date
October 1 2027
Last Update
February 14 2025
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