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

NCT06550934 | Not Yet Recruiting

• 1 other identifier: AO TOP
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvis; Fracture

Keywords

Pelvis; Fragility fracture; Classification; Management; Operative; Outcome

Outcome Measures

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.

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

Study Arms (2)

Isolated posterior surgical fracture stabilization

Procedure: Fracture stabilization

Combined anterior-posterior surgical fracture stabilization

Procedure: Fracture stabilization

Interventions

Fracture stabilization PROCEDURE

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

Combined anterior-posterior surgical fracture stabilization; Isolated posterior surgical fracture stabilization

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead
• AUC - Akademie der Unfallchirurgie: collaborator
• AO Trauma Deutschland e.V.: collaborator

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Richard Stange, Prof

  Universitätsklinikum Münster

  PRINCIPAL INVESTIGATOR

• Lars Grossterlinden, Prof

  Asklepios Klinik Altona, Hamburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Sob, PhD

CONTACT

+41798937428; cynthia.sob@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share