Both Column Fixation Corridor in Pelvic Surgery

NCT06347224 | Completed

• 1 other identifier: BCFC-BCS-VIRTUAL2024
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acetabular Fractures

Keywords

both column screw; percutaneous fixation; acetabulum

Outcome Measures

Primary Outcomes (1)

• Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS)

  This measure evaluates whether the axial fluoroscopic image of the BCFC can be successfully demonstrated across all participant populations, regardless of gender, and whether it's feasible to place two BCS within the BCFC, one anterior and one posterior, in the surgical treatment of pelvic and acetabular fractures. It also examines gender-specific anatomical variations associated with the BCFC and BCS and their implications for surgical planning.

  up to 3 months

Study Arms (2)

male group

OTHER

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.

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

female group

OTHER

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.

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

Interventions

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

The intervention aims to simulate a percutaneous fixation technique that could be applied in a real surgical environment, offering insights into the potential for personalized surgical planning and optimization of outcomes for patients with acetabular fractures. This virtual approach allows for the exploration of various screw placement strategies without the ethical and practical constraints of direct clinical experimentation.

female group; male group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

Related Publications (1)

• Ozturk V, Celik M, Koluman AC, Duramaz A, Kural C, Bilgili MG. Fluroscopy-assisted transiliac antegrade lag screw placement technique in both columns of acetabulum: A novel procedure. Orthop Traumatol Surg Res. 2024 Sep;110(5):103872. doi: 10.1016/j.otsr.2024.103872. Epub 2024 Mar 26.

  PMID: 38548224 BACKGROUND

Study Officials

• Vedat Öztürk, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor in Orthopedics and Traumatology

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: October 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)