Both Column Fixation Corridor in Pelvic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acetabular Fractures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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male group

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.

Group Type OTHER

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

Intervention Type 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

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.

Group Type OTHER

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes