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临床试验/NCT06634472
NCT06634472招募中不适用

Validation of An Artificial Intelligence-Enabled Skin Perforator Segmentation Tool in Computer-Assisted Osteocutaneous Fibular Free Flap Harvest: A Clinical Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
49
试验地点
1
主要终点
predictive accuracy of the artificial intelligence tool in identifying the targeted skin perforators

研究概览

简要总结

Computer-assisted surgery has revolutionized reconstruction with more efficient, accurate, and predictable surgery, as reported in our previous studies. Skin perforators are vessels that travel through muscles and septa to supply the skin. The identification of skin perforators is crucial for a safe fibula osteocutaneous free flap harvest with computer-assisted surgery. Different methods have been proposed in the past, each of which has its own limitations.

Traditionally, skin perforators are identified with a Doppler ultrasound. Berrone et al. measured the locations with a Doppler ultrasound and imported the information back to guide virtual surgical planning. However, their study showed imprecise concordance between handheld Doppler measurements and the actual perforator locations; good correlation between the location of perforators and bone segments was identified in only four out of six cases investigated. To improve on the accuracy, computed tomography angiography was used for skin perforator identification. Battaglia et al. manually marked the perforating vessel location at the subcutaneous level and reported good correlation. However, the manual segmentation of the perforator was at the subcutaneous level only. The course of the perforators, which would be more significant for the design of computer-assisted fibula osteocutaneous free flap harvest, was not shown.

To incorporate the course of skin perforators into fibula osteocutaneous free flap virtual surgical planning, Ettinger et al. first described the technique of manual tracing from computed tomography angiography in 2018 and validated its accuracy in 2022. The median absolute difference between the computed tomography angiography and intraoperative measurements was 3 millimeters. However, reports quoted an average of 2 to 3 hours spent on tracing and modeling the course of the perforators depending on their number and anatomy; consequently, this adds a significant burden to healthcare professionals.

Recently, United Imaging Intelligence has developed an artificial intelligence-based program that offers a potential solution for accurate and efficient localization of skin perforators to be incorporated into the current virtual surgical planning workflow. The proposed study aims to validate its performance in a prospective case series. This will be the first study to investigate the use of an artificial intelligence-enabled program for fibula skin paddle perforator identification.

详细描述

The aim of this single-arm clinical trial is to validate the performance of the artificial intelligence-enabled skin perforator segmentation tool (artificial intelligence tool) in computer-assisted fibula free flap harvest.

To test the predictive accuracy of the artificial intelligence tool in identifying the targeted skin perforators (primary endpoint)

  • The predictive accuracy is calculated from the number of true/false positive, true/false negative targeted perforators.
  • The secondary outcomes include the sensitivity, specificity, positive, and negative predictive values (positive predictive value and negative predictive value respectively).

Our hypothesis is that the artificial intelligence-enabled vessel segmentation tool will demonstrate a high level of accuracy in identifying the fibula skin perforators.

Plan of Investigation:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥18 years, both genders;
  • Provided signed and dated informed consent form;
  • Indicated for immediate or secondary reconstructive surgery with osteocutaneous fibula free flap.

排除标准

  • Patients who are pregnant;
  • Patients who have medically compromised conditions and cannot tolerate surgery;
  • Patients who are unable to receive pre-operative computed tomography angiogram scans, such as those with iodine allergy;
  • Patients who have anatomical variation preventing the safe harvest of fibula free flap.

研究组 & 干预措施

Patients requiring computer-assisted jaw reconstruction with microvascular free flaps

Inclusion criteria

  1. Age ≥18 years, both genders;
  2. Provided signed and dated informed consent form;
  3. Indicated for immediate or secondary reconstructive surgery with osteocutaneous fibula free flap.

Exclusion criteria

  1. Patients who are pregnant;
  2. Patients who have medically compromised conditions and cannot tolerate surgery;
  3. Patients who are unable to receive pre-operative computed tomography, computed tomography Aagiography scans, such as those with iodine allergy;
  4. Patients who have anatomical variation preventing the safe harvest of fibula free flap;

干预措施: artificial intelligence (Other)

结局指标

主要结局

predictive accuracy of the artificial intelligence tool in identifying the targeted skin perforators

时间窗: 36 months

The primary endpoint is the predictive accuracy of the artificial intelligence-enabled skin perforator segmentation tool. When the skin perforator is identified by both the AI-segmentation tool and during the surgery, it will be counted as a true positive (TP). When the perforator is identified by the AI-segmentation tool, but not found during the surgery it is counted as a false positive (FP). When the perforator is seen during the surgery, but not shown by the AI tool, it is a false negative (FN). Finally, a true negative (TN) perforator count will be derived from those subjects, who do not exhibit an FN perforator. The predictive accuracy (PA) is identified as the percentage of true perforators among all the perforators, and is calculated as (TP +TN)/(TP+FP+TN+FN)\*100%.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Yuxiong Su

Clinical Professor

The University of Hong Kong

研究点 (1)

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