Does the Use of a Customized Titanium Reconstruction Plate for Orbital Fractures Result in Better Orbital Volume and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups
研究概览
简要总结
The study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care).
详细描述
Orbital fracture, which accounts for 10-25% of facial fractures, is one of the most difficult facial fractures to treat. The complex bone anatomy and the proximity of adjacent vital structures make reconstruction of these fractures challenging. Inadequate orbital fracture reconstruction leads to cosmetic and functional complications. Cosmetic complications include enophthalmos, which is defined as posterior displacement of the eyeball within the orbit due to changes in the volume of the orbit (bone) relative to its contents (the eyeball and orbital fat). Functional complications include diplopia, defined as a type of vision disorder in which two images are seen of a single object.
This is a prospective randomized clinical study with longitudinal follow-up. The study duration is 2 years, and it will be conducted at Grady Memorial Hospital (GMH). The study targets low-income, urban adults suffering blunt facial trauma who are diagnosed with unilateral orbital fracture.
The purpose of this study is to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants. Main aims of the study are to 1) preoperatively generate a patient-specific model to pre-adapt the titanium mesh for use in unilateral orbital fractures; 2) accurately restore the orbital volume to pre-injury levels; 3) prevent postoperative complications including enophthalmos and diplopia; and 4) decrease the operative time, therefore decreasing overall cost and increasing value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreed to be enrolled in the study.
- •Indications for surgical repair of orbital floor and/ wall fractures are dependent on several factors:
- •Correction or prevention of cosmetic deformity ( enophthalmos or inferior dystopia; disruption of greater than 50% of the orbital floor is likely to cause cosmetically apparent enophthalmos.
- •Correction of unresolved diplopia (7 to 11 days) in the sitting of soft tissue prolapse with a positive forced duction test.
- •Immediate correction of diplopia in the sitting inferior rectus muscle incarceration and a positive forced duction test.
- •Immediate correction in a symptomatic patient with orbital floor ( trapdoor) fracture that has elicited the oculocardiac reflex.
- •At least 18 years of age.
- •Unilateral orbital floor fracture.
- •No history of orbital trauma.
- •Healthy contralateral orbit.
- •Underwent orbital reconstruction.
- •Admitted to GMH.
- •Returned for the 6-week follow-up.
排除标准
- •Refuse study enrollment.
- •Are younger than 18 years.
- •Pregnant women.
- •Unable to obtain consent (cognitively impaired)
- •Are admitted to hospitals other than Grady Memorial Hospital.
结局指标
主要结局
Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups
时间窗: 1 hour post operatively
The Primary Investigator will evaluate the orbital volume using OsiriX (medical software). Orbital volume measurements will be obtained to compare the injured and uninjured (contralateral) orbital volumes. OsiriX MD offers advanced processing techniques and has the ability to precisely measure orbital volume. It also utilizes the DICOM data from the immediate postoperative CT scans.
次要结局
- Number of Subjects With Infection Between the Treatment and Control Groups(1 week, 3 weeks, and 6 weeks postoperatively.)
- Mean Operating Time in Minutes Between the Treatment and Control Groups(Intraoperative time period)
- Number of Subjects With Intraocular Pressure (IOP) > 40 mmHg Between the Treatment and Control Groups(1 week, 3 weeks, and 6 weeks postoperatively.)
- Number of Subjects With Inability to Achieve the Normal Orbital Contour Between the Treatment and Control Groups(Up to 6 hours postoperatively)
- Number of Subjects With Infraorbital Nerve Injury Between the Treatment and Control Groups(1 week, 3 weeks, and 6 weeks postoperatively.)
- Number of Subjects With Reduction of Orbital Volume to Less Than 2 cm3 Between the Treatment and Control Groups(1 week, 3 weeks, and 6 weeks postoperatively.)
- Mean Length of Stay in Hospital Measured in Days Between the Treatment and Control Groups(up to 2 weeks)
- Number of Subjects With a Difference of More Than 2 mm Between the Two Orbits Between the Treatment and Control Groups(1 week, 3 weeks, and 6 weeks postoperatively.)
- Mean Treatment Amount in Dollars Between the Treatment and Control Groups(up to 2 weeks)
- Number of Subjects That Develop Restricted Extraocular Motility That Was Not Present Before Between the Treatment and Control Groups(1 week, 3 weeks, and 6 weeks postoperatively.)
研究者
Dina Amin
Assistant Professor
Emory University