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Completed

NCT Number: NCT07115602

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

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.

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Key information

Conditions

Pelvic Ring Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • Review of computed tomography images alone.
  • Addition of a standard anteroposterior pelvic radiograph with a pelvic binder.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Arbeitsgemeinschaft für Osteosynthesefragen / Orthopaedic Trauma Association (AO/OTA) classification

    Time frame: From enrollment to the end of primary injury evaluation at day 1

    Each expert determines the AO/OTA classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation:

    • Review of computed tomography images alone;
    • Addition of a standard anteroposterior pelvic radiograph with a pelvic binder;
    • Addition of a standard anteroposterior pelvic radiograph without a pelvic binder.

    Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.

  2. Young and Burgess classification

    Time frame: From enrollment to the end of primary injury evaluation at day 1

    Each expert determines the Young and Burgess classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 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. Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.

  3. Pelvic ring mechanical stability assessment

    Time frame: From enrollment to the end of primary injury evaluation at day 1

    Each expert determines the mechanical stability of the pelvic ring injury (pelvic ring fully stable, pelvic ring horizontally unstable, pelvic ring fully unstable) presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 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. Each one of the 3 provided assessments is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of mechanical stability assessment.

  4. Surgical fixation plan

    Time frame: From enrollment to the end of primary injury evaluation at day 1

    Each expert determines the surgical fixation plan (no fixation needed, anterior fixation only, posterior fixation only, lumboelvic fixation only, anterior and posterior fixation, anterior and lumbopelvic fixation) for the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 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. Each one of the 3 provided plans is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of surgical fixation planning.

Sponsors and collaborators

Lead sponsor

Axel Gamulin

Other

Registry information

Official study title

Retrospective Multi-expert Diagnostic Imaging Evaluation of Pelvic Ring Injuries: Methodology for Transferring Large DICOM Data Volumes to Remote Experts, and Survey Designed to Isolate Information Obtained From Different Imaging Modalities

Important dates

Study start
2012
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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