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 (AO TOP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvis; Fracture
• Intervention / Treatment: Procedure: Fracture stabilization

• Study Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: Cynthia Sob, PhD; Phone Number: +41798937428; Email: cynthia.sob@aofoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Isolated posterior surgical fracture stabilization	Procedure: Fracture stabilization; isolated posterior surgical fracture stabilization vs. combined anterior-posterior surgical fracture stabilization
Combined anterior-posterior surgical fracture stabilization	Procedure: Fracture stabilization; isolated posterior surgical fracture stabilization vs. combined anterior-posterior surgical fracture stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Collaborators: AO Trauma Deutschland; AUC - Akademie der Unfallchirurgie
• Investigators: Principal Investigator: Richard Stange, Prof, Universitatsklinikum Munster; Principal Investigator: Lars Grossterlinden, Prof, Asklepios Klinik Altona, Hamburg

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Outcome; Management; Classification; Pelvis; Operative; Fragility fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: AO TOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No