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Completed

NCT Number: NCT06634251

Antegrade Screw Placement Technique in Anterior Column of Acetabulum

This retrospective observational study aims to define the optimal antegrade entry point for screw placement in the anterior column fixation corridor (ACFC) of the acetabulum. Using fluoroscopic visualization techniques, the study examines computed tomography (CT) scans from 500 healthy adult patients to simulate screw placement and measure anatomical parameters. The goal is to determine patient-specific entry points and to assess the feasibility of screw placement using axial fluoroscopic views. The study also investigates gender-specific anatomical variations to provide insights for safer and more precise screw placement during anterior column fixation in pelvic surgery.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology

Istanbul, Turkey (Türkiye)

About this study

This study focuses on developing and validating a fluoroscopic visualization technique for identifying the optimal antegrade entry point (OAEP) in the anterior column fixation corridor (ACFC) of the acetabulum during pelvic surgery. Using three-dimensional reconstructions from pelvic computed tomography (CT) data of 500 healthy adults, the study simulates screw placement within the ACFC. A cylinder representing the screw is inserted virtually through the OAEP, ensuring that it remains within the confines of the fixation corridor without breaching its boundaries. The study records anatomical measurements, including the corridor's diameter, length, and the angles required for sagittal and coronal plane inclinations to visualize the OAEP.

The study also examines gender-specific anatomical variations, including differences in ACFC diameter, length, and required fluoroscopic angles. By defining patient-specific entry points and establishing a reliable fluoroscopic technique, this study aims to provide a practical and accessible method for anterior column fixation, minimizing complications and improving the safety and precision of screw placement in pelvic surgeries.

This novel approach has the potential to offer a cost-effective alternative to more expensive navigation systems, making it widely applicable in clinical settings.

Who can participate

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

Inclusion criteria

  • Patients with pelvic computed tomography (CT) scans that provide complete anatomical details of the pelvis.
  • Patients aged 18 to 65 years.
  • Patients with fully matured bone structures, without evidence of fractures, deformities, or prior orthopedic surgery.
  • Patients with no history of rheumatologic disease, advanced osteoporosis, bone metastasis, or metabolic bone disorders.

Exclusion criteria

  • Patients with pelvic CT scans that do not fully display the anatomical structures.
  • Patients younger than 18 years or older than 65 years.
  • Patients with pelvic fractures, deformities, or prior orthopedic surgeries.
  • Patients with incomplete clinical or radiological data.
  • Patients with rheumatologic sequelae, bone metastasis, or metabolic bone diseases.

Treatment and study plan

No intervention

Other

This study is purely observational and does not involve any direct intervention. It utilizes retrospective analysis of computed tomography (CT) scans to simulate the fluoroscopic visualization and screw placement technique in the anterior column fixation corridor (ACFC) of the acetabulum. The objective is to define the optimal antegrade entry point and assess anatomical parameters without performing any physical intervention on the participants.

Primary outcomes

  1. Axial Visualization Success

    Time frame: During the simulation of the fluoroscopic imaging, typically within 1 hour of starting the procedure.

    Success in obtaining axial fluoroscopic visualization of the anterior column fixation corridor (ACFC) and optimal antegrade entry point (OAEP).

  2. Screw Placement Feasibility

    Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.

    Feasibility of virtual screw placement within the ACFC without breaching the corridor boundaries.

Secondary outcomes

  1. ACFC Diameter (ACFC-R)

    Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.

    Measurement of the ACFC diameter in millimeters (R) to assess screw placement feasibility.

  2. ACFC Length (ACFC-L)

    Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.

    Measurement of the ACFC length in millimeters (L) to assess screw placement feasibility.

  3. Sagittal Plane Inclination (SPI)

    Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.

    Measurement of the sagittal plane inclination (SPI) required for optimal fluoroscopic visualization of the ACFC.

  4. Coronal Plane Inclination (CPI)

    Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.

    Measurement of the coronal plane inclination (CPI) required for optimal fluoroscopic visualization of the ACFC.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Defining Fluoroscopic Visualization Technique for Optimal Antegrade Entry Point and Anatomical Parameters in Anterior Column Fixation Corridor for Pelvic Surgery: A Novel Perspective

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

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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