Plagiocephaly, Nonsynostotic
Conditions
Brief summary
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
Detailed description
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).
Interventions
DEVICESerkel 3D CRO
Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants with deformational plagiocephaly, who qualify for cranial remolding treatment were fitted with a (new to US market) 3D printed cranial remolding orthosis.
Eligibility
Sex/Gender
ALL
Age
4 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* 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%)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cranial Measurements as Measured by CVA | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
19 subjects consented but 1 screen failed and did not start treatment with the device. Therefore, only 18 considered enrolled and started treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Serkel 3D CRO: Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Serkel 3D CRO Arm |
|---|---|
| Age, Categorical <=18 years | 18 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 30.4 weeks |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Change in Cranial Measurements as Measured by Cephalic Index
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.
Time frame: Baseline, approximately 4-6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Serkel 3D CRO Arm | Change in Cranial Measurements as Measured by Cephalic Index | Cephalic Index at start of treatment | 89.8 percentage |
| Serkel 3D CRO Arm | Change in Cranial Measurements as Measured by Cephalic Index | Cephalic Index at end of treatment | 86.8 percentage |
Primary
Change in Cranial Measurements as Measured by CVA
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.
Time frame: Baseline, approximately 4-6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Serkel 3D CRO Arm | Change in Cranial Measurements as Measured by CVA | Cranial Vault Asymmetry at start of treatment | 11.6 mm |
| Serkel 3D CRO Arm | Change in Cranial Measurements as Measured by CVA | Cranial Vault Asymmetry at end of treatment | 7.1 mm |