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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fracture stabilization.
- Who it may be relevant to
- Registry conditions: Pelvis; Fracture. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Fracture stabilization
isolated posterior surgical fracture stabilization vs. combined anterior-posterior surgical fracture stabilization
Primary outcome measures
- Pain rating [Time frame: Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06550934 · AO TOP