Advanced Visuohaptic Surgical Planning for Trauma Surgery
2020年7月2日 更新者：VA Office of Research and Development
This study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.
研究概览
详细说明
The proposed tool will allow surgeons from different specialties to simulate, plan and iterate on complex procedures based on individual patient data in 3-D from a CT scan.
The software will allow surgeons to both see and feel the results of their interventions - for example, the quality of the bite or bone alignment of a reconstructed jaw following severe trauma - before the actual surgery, leading to better planning, fewer errors, shortened surgery time and improved outcomes for the patients.
The purpose of this study is the evaluation of a visuohaptic planning system for mandibular trauma surgery that is based on interactive manipulation of CT data.
研究类型
观察性的
注册 (实际的)
3
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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San Francisco、California、美国、94121
- VA Medical Center, San Francisco
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Study population will veterans who present to the Oral/Maxillofacial Surgery Clinic at the San Francisco VA Medical Center.
The study will use pre-existing data from patients undergoing reconstructive facial surgery at the San Francisco VA with clinic indications that require preoperative CT scans and preoperative radiographs as well as model casts.
描述
Inclusion Criteria:
- Craniofacial deformity, including post-traumatic, congenital or acquired deformity
- Patients who have already have surgery because there was a clinical indication for surgical correction
Exclusion Criteria:
- No craniofacial deformity
- No clinical indication for surgical correction
- Contraindication for surgical correction
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Group 1
15 patients who underwent surgical repair of mandibular fractures at San Francisco VA Medical Center
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Patients will undergo whatever needed surgical repair of maxillofacial trauma that is necessary.
Records such as CT imaging and plaster models of the jaws will be utilized in the standard way to plan and carry out the surgery.
The CT scan will also be used within the visuohaptic computational environment to develop and evaluate the user interface.
The amount of time taken to work up and plan surgery using standard surgical practice and using the computational platform will be compared.
Real surgical outcome will be compared to the simulated surgical outcome using the proposed software tool.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Deviation From Actual Surgical Outcome During Virtual Repair of Mandibular Fractures, Using the Novel Visuohaptic Computational Platform That Was Developed by the Investigators
大体时间：6 months
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The virtual surgical outcome was compared to the actual surgical outcome.
This was accomplished by measuring distances (mm) and angles between specific mandibular anatomic points in the virtual environment and comparing it to the same distances (mm) and angles between specific mandibular anatomic points in the actual surgical outcome, as seen in a 3D rendering derived from the patient's postoperative CT scan.
The actual surgical repair was considered to be the gold standard.
A deviation of more than 10% between the virtual surgical repair and the actual surgical repair was considered to be above threshold (inaccurate virtual fracture repair).
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment
大体时间：3 years
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The addition of automation features for the visuohaptic virtual surgical planning environment was envisioned to make it possible to predict the number, type, size, and position of reconstruction hardware (bone plates and screws) that would best fit the virtually repaired mandibular fractures.
The goal was to compare the hardware configuration selected and used in the actual surgical repair for the 3 participating patients with what the software predicted.
Unfortunately, the software development proved to be difficult to add this automated feature.
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3 years
|
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Implementation and Test of the Telemedicine Prototype
大体时间：3 years
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Measurement of the accuracy of the virtual surgical repair generated by the surgeon operating the software when a remote surgeon digitally sends a CT scan of a patient with an acute mandibular fracture(s).
The telemedicine interface would require an automated method to segment the CT scan into the fractured components.
The operator would manipulate the bone fractures, select the hardware type and size for "best fit", and generate a report back to the remote surgeon.
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3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rebeka Silva, DMD、VA Medical Center, San Francisco
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Schvartzman SC, Silva R, Salisbury K, Gaudilliere D, Girod S. Computer-aided trauma simulation system with haptic feedback is easy and fast for oral-maxillofacial surgeons to learn and use. J Oral Maxillofac Surg. 2014 Oct;72(10):1984-93. doi: 10.1016/j.joms.2014.05.007. Epub 2014 May 24.
- Forsslund J, Chan S, Selesnick J, Salisbury K, Silva RG, Blevins NH. The effect of haptic degrees of freedom on task performance in virtual surgical environments. Stud Health Technol Inform. 2013;184:129-35.
- Girod S, Schvartzman SC, Gaudilliere D, Salisbury K, Silva R. Haptic feedback improves surgeons' user experience and fracture reduction in facial trauma simulation. J Rehabil Res Dev. 2016;53(5):561-570. doi: 10.1682/JRRD.2015.03.0043.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年11月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2016年2月1日
研究注册日期
首次提交
2010年1月22日
首先提交符合 QC 标准的
2010年1月22日
首次发布 (估计)
2010年1月26日
研究记录更新
最后更新发布 (实际的)
2020年7月7日
上次提交的符合 QC 标准的更新
2020年7月2日
最后验证
2020年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.