Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2024-04-05

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Plagiocephaly, Nonsynostotic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants with deformational plagiocephaly, who qualify for cranial remolding treatment were fitted with a (new to US market) 3D printed cranial remolding orthosis.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Serkel 3D CRO

Intervention Type DEVICE

Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis

Interventions

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Serkel 3D CRO

Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

4 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes