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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorAO Innovation Translation Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial population

Patients 65 years or older with a fragility fracture in the pelvis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fracture stabilization

    Procedure/Surgery

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

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Isolated posterior surgical fracture stabilization1 intervention
Group B: Combined anterior-posterior surgical fracture stabilization1 intervention

Trial outcomes

Primary outcomes

1

Pain rating

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AO Innovation Translation Center

Lead sponsor

AUC - Akademie der Unfallchirurgie

Collaborator

AO Trauma Deutschland e.V.

Collaborator

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