A Pilot Study - to Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly, a Pre-market Fitting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Cranial Measurements as Measured by CVA
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market
详细描述
The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market. Serkel is an Australian company that specializes in the fabrication of 3D printed cranial remolding orthoses (CRO) to treat infants with deformational head shapes. Serkel has made over 600 helmets that have treated children with deformational head shapes in Australia, however it's specific helmet design is not FDA approved to provide treatment in the United States market. Serkel is seeking FDA approval of their brand of CRO by providing CRO's for pre market fitting. The study includes treatment for children who have been screened and diagnosed with a positional deformational head shape. Those who qualify for a FDA approved CRO treatment and were given the option to participate in the study. If they were interested, an inform consent provided and reviewed together. Cargivers then had the option to enroll. In total, 18 participants were enrolled. Fabrication scans were taken of the subjects head, and they returned 2 weeks later for fitting of the 3D printed cranial remolding orthosis, and seen for follow up every 2-4 weeks until treatment was complete (head shape corrected or participant outgrew CRO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants between the ages of 4-18 months at evaluation
- •Participants with physician prescription of CRO treatment
- •Participants with physician diagnosis of deformational plagiocephaly
- •Participants who skulls measurements qualify them for standard CRO treatment (CVA measurement is greater than 6mm and Cephalic Index is greater than 92%)
排除标准
- •Participants younger than 4 months at evaluation
- •Participants older than 18 months at evaluation
- •Participants without physician prescription for CRO treatment
- •Participants without physician diagnosis of deformational plagiocephaly
- •Participants whos skull measurements or asymmetries do not qualify them for standard CRO treatment
研究组 & 干预措施
Serkel 3D CRO Arm
Once parents/caregivers decide and consent for their child to participate and be treated with the pre-market Serkel 3D CRO, infant's head will be scanned and CRO will be fabricated and fitted 2 weeks later. The orthosis is nearly identical to existing FDA approved devices.
干预措施: Serkel 3D CRO (Device)
结局指标
主要结局
Change in Cranial Measurements as Measured by CVA
时间窗: Baseline, approximately 4-6 months
Skull measurement are taken at every appointment the participant attends. At the end of treatment, the measurements will be compared to the participants starting measurements. Measurements can be taken by hand, using a tape measure and calipers. Or using an FDA approved scanner -- OMEGA Scanner 3D or Orthomerica STARscanner. * Cranial Vault Asymmetry (CVA) measures the difference between the lengths of two diagonals on the top of the skull. These diagonals are measured at a 30-degree angle from the midline. The CVA equation is: CVA = A - B, where A and B are the lengths of the longer and shorter diagonals, respectively. CVA is measured in millimeters.
Change in Cranial Measurements as Measured by Cephalic Index
时间窗: Baseline, approximately 4-6 months
Skull measurement are taken at every appointment the participant attends. At the end of treatment, the measurements will be compared to the participants starting measurements. Measurements can be taken by hand, using a tape measure and calipers. Or using an FDA approved scanner -- OMEGA Scanner 3D or Orthomerica STARscanner. * The Cephalic Index (CI) is a measurement of head shape in infants, calculated by dividing head width by head length and multiplying by 100. A CI within the normal range (75-90%) indicates a typical head shape, while deviations, especially those leading to brachycephaly (CI \> 90%) or dolichocephaly (CI \< 76%), may be associated with developmental or medical concerns.
次要结局
未报告次要终点
研究者
Dara Spivey
Principle Investigator
University of Texas Southwestern Medical Center