跳至主要内容
临床试验/NCT06347224
NCT06347224已完成不适用

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

Bakirkoy Dr. Sadi Konuk Research and Training Hospital2 个研究点 分布在 2 个国家目标入组 400 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Vedat Öztürk

Specialist Doctor in Orthopedics and Traumatology

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (2)

Loading locations...

相似试验

进行中(未招募)
不适用
Fixation and Stability of the Trident® II Clusterhole HA ShellsHip Replacement Arthroplasty
NCT03724058Region Skane87
进行中(未招募)
1 期
A Phase 2 Study for the Treatment of COVID 19 in Hospitalised Patients
EUCTR2020-001736-95-GBniversity Hospital Southampton NHS Foundation Trust1,800
进行中(未招募)
不适用
To test whether the experimental drug GDC-0449 is safeand effective for advanced basal cell carcinoma.• metastatic BCC with histologic confirmation of a distant BCC metastasis (e.g., lung, liver, lymph nodes, or bone)• locally advanced BCC considered inoperable or with medical contraindication to surgery• nevoid BCC syndrome (Gorlin syndrome), meeting the criteria for locally advanced or metastatic diseaseMedDRA version: 14.1Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2008-004945-27-GBGenentech, Inc.100
进行中(未招募)
不适用
To test whether the experimental drug GDC-0449 is safeand effective for advanced basal cell carcinoma.• metastatic BCC with histologic confirmation of a distant BCC metastasis (e.g., lung, liver, lymph nodes, or bone)• locally advanced BCC considered inoperable or with medical contraindication to surgery• nevoid BCC syndrome (Gorlin syndrome), meeting the criteria for locally advanced or metastatic diseaseMedDRA version: 14.1Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2008-004945-27-BEGenentech, Inc.100
进行中(未招募)
不适用
To test whether the experimental drug GDC-0449 is safeand effective for advanced basal cell carcinoma.• metastatic BCC with histologic confirmation of a distant BCC metastasis (e.g., lung, liver, lymph nodes, or bone)• locally advanced BCC considered inoperable or with medical contraindication to surgery• nevoid BCC syndrome (Gorlin syndrome), meeting the criteria for locally advanced or metastatic diseaseMedDRA version: 14.1Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2008-004945-27-DEGenentech, Inc.100