Clinical trial NCT06347224: Both Column Fixation Corridor in Pelvic Surgery
Official title: Navigating the Both Column Fixation Corridor: Anatomical Insights From a Virtual Pelvic Screw Placement Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acetabular Fractures
Keywords: both column screw
percutaneous fixation
acetabulum
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS)
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
Study officials:
affiliation: Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
name: Vedat Öztürk, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.