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CompletedNCT06634251Updated Oct 9, 2024

Antegrade Screw Placement Technique in Anterior Column of Acetabulum

An observational study in Acetabulum Fracture, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Acetabulum Fracture

Keywords

  • acetabulum fracture
  • virtual study
  • anterior column
03

In context

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 120 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population consists of 500 healthy adults, including 250 males and 250 females, aged between 18 and 65 years. Participants were selected based on their pelvic computed tomography (CT) scans, which displayed complete and fully matured pelvic anatomy. Individuals with prior orthopedic surgeries, pelvic fractures, deformities, or any bone pathologies such as rheumatologic diseases, advanced osteoporosis, and bone metastasis were excluded. The study focuses on assessing anatomical parameters and optimal entry points for anterior column fixation using fluoroscopic guidance.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • male group

    This group consists of 250 healthy male adults whose pelvic CT scans were analyzed to define the optimal antegrade entry point and anatomical parameters for anterior column fixation. The fluoroscopic visualization technique and screw placement were simulated to assess anatomical variations and feasibility specific to the male cohort.

    Other: No intervention

  • female group

    This group consists of 250 healthy female adults whose pelvic CT scans were analyzed to define the optimal antegrade entry point and anatomical parameters for anterior column fixation. The fluoroscopic visualization technique and screw placement were simulated to assess anatomical variations and feasibility specific to the female cohort.

    Other: No intervention

Interventions

  • OtherNo intervention

    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.

06

What researchers measure

Primary outcomes

  1. Axial Visualization Success

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

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

  2. Screw Placement Feasibility

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

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

Secondary outcomes

  1. ACFC Diameter (ACFC-R)

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

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

  2. ACFC Length (ACFC-L)

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

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

  3. Sagittal Plane Inclination (SPI)

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

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

  4. Coronal Plane Inclination (CPI)

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

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

07

Study locations

1 site
  • Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
    Istanbul, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06634251
Responsible party
Vedat Öztürk (Specialist Doctor in Orthopedics and Traumatology, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Principal investigator
First posted
Oct 9, 2024
Start date
Jun 1, 2024
Primary completion
Jul 1, 2024
Completion
Aug 1, 2024
Last update
Oct 9, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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