Clinical trial NCT06634251: Antegrade Screw Placement Technique in Anterior Column of Acetabulum
Official title: Defining Fluoroscopic Visualization Technique for Optimal Antegrade Entry Point and Anatomical Parameters in Anterior Column Fixation Corridor for Pelvic Surgery: A Novel Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabulum Fracture
Keywords: acetabulum fracture
virtual study
anterior column
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Axial Visualization Success
timeFrame: During the simulation of the fluoroscopic imaging, typically within 1 hour of starting the procedure.
measure: Screw Placement Feasibility
timeFrame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Secondary outcomes:
measure: ACFC Diameter (ACFC-R)
timeFrame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
measure: ACFC Length (ACFC-L)
timeFrame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
measure: Sagittal Plane Inclination (SPI)
timeFrame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
measure: Coronal Plane Inclination (CPI)
timeFrame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
Study officials:
References: