Antegrade Screw Placement Technique in Anterior Column of Acetabulum

NCT06634251 | Completed

• 1 other identifier: 2024/45-2024-04-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acetabulum Fracture

Keywords

acetabulum fracture; virtual study; anterior column

Outcome Measures

Primary Outcomes (2)

• Axial Visualization Success

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

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

• Screw Placement Feasibility

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

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

Secondary Outcomes (4)

• ACFC Diameter (ACFC-R)

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

• ACFC Length (ACFC-L)

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

• Sagittal Plane Inclination (SPI)

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

• Coronal Plane Inclination (CPI)

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

Study Arms (2)

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

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.

female group; male group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor in Orthopedics and Traumatology

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 9, 2024
• Study Start: June 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

TU (1)