Clinical trial NCT06831513: Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
Official title: A Pilot Study - to Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly, a Pre-market Fitting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plagiocephaly, Nonsynostotic
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 18
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cranial Measurements as Measured by CVA
timeFrame: Baseline, approximately 4-6 months
measure: Change in Cranial Measurements as Measured by Cephalic Index
timeFrame: Baseline, approximately 4-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTSouthwestern University - School of Health Professions
state: Texas
Study officials:
affiliation: University of Texas Southwestern Prosthetics Orthotics
name: Dara Spivey, MSOP
role: PRINCIPAL_INVESTIGATOR
References: