Craniofacial Applications of 3D Printing
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
3D printing is a technology that allows for physical creation of a 3D model (usually made of plastic) based on computer generated 3D images from CT scans. The 3D images of craniofacial skeleton using computer software are routinely generated and, in turn, these 3D images can be used to create a plastic 3D model using a 3D printer.
Unstable or comminuted facial fractures need to be reduced and rigidly fixated using titanium plates and screws. Bending and shaping of the plates is usually performed by free-hand based on the surgeon's estimation of what best fits the fracture.
Often, bending the titanium plates to the shape of pre-injury skeletal contour is difficult when the bone is fractured into many pieces or is unstable, or when the patient is edentulous (missing several teeth). The process can increase the time spent in surgery and the bent plates may not snugly fit the fracture. For these difficult cases, one option is to use commercially manufactured 3D printed patient-specific models. The patient-specific models provide the benefit of correct shape / form for increased surgical accuracy, and decreased intra-operative time. However these commercial models are manufactured at distant facilities and usually require more than 7 days before delivery. As such, they delay time to surgery and cannot be used for urgent surgery. Additionally, the commercially manufactured implants are expensive, significantly increasing the cost of treatment.
The purpose of this study is to explore whether custom plastic models 3D printed at Shock Trauma Center and used for bending and shaping plates for facial fracture repair can improve results of facial fracture reconstruction.
Our plastic surgery division will design and produce facial bone 3D model of patients (with facial fractures) using an in-house 3D printer, then use the 3D model to contour the hardware pre-op or intra-op at the time of fracture repair. We believe that we can achieve better repair, shorter surgery time, and save hardware cost.
详细描述
The purpose of this study is to:
- produce 3D printed craniofacial models of patients with facial fracture, then use the 3D models
- contour (or pre-bend) the appropriate hardware pre-op that is specific for the patient.
Fracture repair in the operating room entails exposure and reduction of the fracture, followed by contouring the hardware to the correct shape to maintain the fracture reduction. However, in unstable or comminuted fractures or in patients missing several teeth, contouring the plate to the correct shape can be time consuming and, sometimes, the plate shape can be inaccurate. Our hypothesis is that using our own 3D model printed on-site to "pre-bend" plates will save intra-operative time and cost, and achieve superior clinical outcome.
Patients will be enrolled to participate if they meet inclusion and exclusion criteria, and provide informed consent.
Additionally, for study subjects, protected health information such as name, date of birth, medical record number, and demographic information (age, sex, ethnic group), Billing and payment information with medical justification, clinical information related to the procedure and follow-up visits will be handled by research personnel for research purposes.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with face CT scans
- •Patients with facial fractures
- •Patient age 12 years or older
排除标准
- •Patients without CT scan
- •Patients with facial fractures that do not require rigid fixation using hardware
- •Patients with facial fractures that do not have normal contralateral bony structures
- •Patient age less than 12 years
结局指标
主要结局
Operative time
时间窗: 24 hours
Duration of fracture fixation
次要结局
未报告次要终点
研究者
Arthur Nam
Assistant Professor
University of Maryland, Baltimore