Both Column Fixation Corridor in Pelvic Surgery

Acetabular Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06347224
• Other study ID #: BCFC-BCS-VIRTUAL2024
• Status: Completed
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acetabular Fractures

Intervention

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

Locations

Country	Name	City	State
Turkey	Bakirköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & 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 Mar 26:103872. doi: 10.1016/j.otsr.2024.103872. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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