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

Not yet recruiting

• Conditions: Pelvis; Fracture
• Interventions: Procedure: Fracture stabilization

• Registration Number: NCT06550934
• Lead Sponsor: AO Innovation Translation Center

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Study Start: 2025-03
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Isolated posterior surgical fracture stabilization	Fracture stabilization	-
Combined anterior-posterior surgical fracture stabilization	Fracture stabilization	-

Primary Outcome Measures

Name	Time	Method
Pain rating	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.