Both Column Fixation Corridor in Pelvic Surgery

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Completed

Conditions: Acetabular Fractures

Treatments: Procedure: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.

Study type: Interventional

Funder types: Other

Identifiers

NCT06347224

BCFC-BCS-VIRTUAL2024

Details and patient eligibility

About

The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. This study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application.

Full description

Pelvic CT data will be collected from 400 healthy adults, including 200 males and 200 females. The Synapse software will be utilized to simulate the placement of both anterior and posterior Both Column Screws (BCS) in the Both Column Fixation Corridor (BCFC). Screws will be virtually implanted into the BCFC using the "Ozturk Procedure," a technique developed based on clinical practice. Measurements will include the thickness and length of each BCS for both anterior (aBCS) and posterior (pBCS) placements, as well as the distances from the screw centers to the spina iliaca anterior superior (SIAS). Additionally, the necessary caudo-cranial (CCT) and centro-lateral tilts (CLT) for achieving axial fluoroscopic visualization of the BCFC will be measured.

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18 to 65 years.
• Both male and female participants.
• Participants with healthy pelvic anatomy as determined by CT imaging, without any previous fractures, deformities, or surgical interventions that could alter the pelvic structure.

Exclusion criteria

• History of pelvic or acetabular fractures.
• Previous pelvic surgeries that could alter the anatomical structure.
• Conditions significantly affecting bone quality, such as osteoporosis or metabolic bone diseases.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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400 participants in 2 patient groups

male group

Other group

Description:

Male Group: In this study, the male group consists of 200 healthy adult men selected from hospital radiology archive records, who have undergone pelvic computed tomography (CT) scans for various reasons. These individuals were chosen excluding those with pelvic fractures, anatomical abnormalities, or severe osteoporosis. The age range of the male group is between 18 and 65 years, with a median age of approximately 39.4 years. Analyses conducted on the male group focus on concepts such as the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS), evaluating the feasibility, gender-specific anatomical differences, and potential advantages of this new fixation technique.

Treatment:

Procedure: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.

female group

Other group

Description:

Female Group: Similarly, the female group comprises 200 healthy adult women who have had pelvic CT scans for any reason, selected from hospital radiology archives. Like the male group, these individuals meet the specific criteria set for the study. The age range for the female group is also between 18 and 65 years, with a median age comparable to that of the male group. The analysis of the female group centers on the feasibility of applying BCFC and BCS, taking into account the unique anatomical structures of the female pelvis and their implications for surgical planning. The work on this group aims to enhance the understanding of gender-specific anatomical variations and integrate this knowledge into surgical practices.

Treatment:

Procedure: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.