Both Column Fixation Corridor in Pelvic Surgery

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.

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Key information

Conditions

Acetabular Fractures

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Time frame: up to 3 months

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.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Navigating the Both Column Fixation Corridor: Anatomical Insights From a Virtual Pelvic Screw Placement Study

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Apr 4, 2024
Registry last updated: Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed