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

NCT ID: NCT06550934

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-10-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Isolated posterior surgical fracture stabilization

Fracture stabilization

Intervention Type: PROCEDURE

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

Combined anterior-posterior surgical fracture stabilization

Fracture stabilization

Intervention Type: PROCEDURE

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

Interventions

Fracture stabilization

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AUC - Akademie der Unfallchirurgie

UNKNOWN

Sponsor Role: collaborator

AO Trauma Deutschland e.V.

OTHER

Sponsor Role: collaborator

AO Innovation Translation Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Stange, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Münster

Lars Grossterlinden, Prof

Role: PRINCIPAL_INVESTIGATOR

Asklepios Klinik Altona, Hamburg

Central Contacts

Cynthia Sob, PhD

Role: CONTACT

cynthia.sob@aofoundation.org

+41798937428

Other Identifiers

AO TOP

Identifier Type: -

Identifier Source: org_study_id