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

NCT06831513 | Completed Results FDA Device

• 1 other identifier: STU-2022-0287
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Plagiocephaly, Nonsynostotic

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, approximately 4-6 months

• 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.

  Baseline, approximately 4-6 months

Study Arms (1)

Serkel 3D CRO Arm

OTHER

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.

Device: Serkel 3D CRO

Interventions

Serkel 3D CRO DEVICE

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

Serkel 3D CRO Arm

Eligibility Criteria

• Age: 4 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UTSouthwestern University - School of Health Professions

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic

Condition Hierarchy (Ancestors)

Plagiocephaly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

A limitation was not having statistical analysis planned. Only a descriptive analysis was performed (start and completion of head shape measurements) and study was intended to collect de-identified data on a small sample size and never intended to publish. The funding sponsor, Serkel, went bankrupt and the company dissolved shortly after trials were complete, the final de-indentified data was not shared with Serkel.

Results Point of Contact

• Title: Dara Spivey, CPO, LPO
• Organization: UT Southwestern Medical Center - School of Health Professions

dara.spivey@utsouthwestern.edu

(214) 645-8250

Study Officials

• Dara Spivey, MSOP

  University of Texas Southwestern Prosthetics Orthotics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

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

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: May 24, 2022
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)