Methodology to Transfer High Volumes of Data for Distant Expert Radiographic Evaluation of Pelvic Ring Injuries

NCT ID: NCT07115602

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2025-05-31

Brief Summary

The aim of this retrospective cohort study based on a prospectively filled registry was to determine whether standard anteroposterior pelvic radiographs with and without pelvic binder provide valuable information on pelvic ring injury anatomy and stability when compared to computed tomography images alone. The ultimate goal was to improve the management of these injuries in both emergency and definitive treatment.

Detailed Description

At the core of the study was a stepwise pelvic imaging evaluation of pelvic ring injury patients by a panel of international pelvic trauma experts. The assessment was conducted in 3 sequential steps:

1. Review of computed tomography images alone.

2. Addition of a standard anteroposterior pelvic radiograph with a pelvic binder.

3. Addition of a standard anteroposterior pelvic radiograph without a pelvic binder.

At each step, experts independently classified the injury (Arbeitsgemeinschaft für Osteosynthsesfragen / Orthopaedic Trauma Association and Young and Burgess classifications), assessed mechanical stability and recommended definitive treatment.

Conditions

Pelvic Ring Injury

Study Design

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

Study Groups

Pelvic ring injury patients with operative management within 3 weeks from injury

Pelvic ring injury patients with operative management within 3 weeks from injury

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 1) admission to the author's institution between January 2012 and December 2023;
• 2) high-energy pelvic ring injury involving a non-pathologic pelvis (i.e., no prior injury, pathology, or surgery compromising image interpretation), surgically treated within three weeks of injury;
• 3) age ≥18 years at the time of trauma.

Exclusion Criteria

• 1) imaging acquired after any kind of surgical stabilization (i.e. emergent external fixation), which could bias injury assessment;
• 2) incomplete imaging dataset, defined as the absence of any of the following: pelvic computed tomography, standard anteroposterior pelvic radiograph with pelvic binder, and standard anteroposterior pelvic radiograph without pelvic binder;
• 3) poor image quality, including incomplete pelvic coverage, computed tomography slice thickness >2 mm, motion artifacts, or incompatibility with the image viewer used for the study;
• 4) documented (written or verbal) refusal to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axel Gamulin

OTHER

Sponsor Role: lead

Responsible Party

Axel Gamulin

Dr Axel GAMULIN, MD, PD, CC, FMH, Senior Staff Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

VMOO_MDThesis_M_&_M

Identifier Type: -

Identifier Source: org_study_id