Cranial Remolding Orthosis Registry

A registry of infants fitted with a cranial remolding orthosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Plagiocephaly; Brachycephaly; Asymmetric Head
• Intervention / Treatment: Device: MyCRO Band; Device: Traditional CRO

Detailed Description

The intention of the CRO registry is to gather real-world data of traditional and 3D-printed cranial remolding orthoses to compare outcomes.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jared Howell; Phone Number: 8328644322; Email: jared.howell@ottobock.com

Study Locations

• United States
  • Michigan
    • Madison Heights, Michigan, United States, 48071
      • Wright & Filippis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All infants who have been scanned and fitted with a cranial remolding orthosis

Description

Inclusion Criteria:

• Patient has been evaluated and successfully scanned for a MyCRO Band or similar CRO
• Patient's parent(s) or legal guardian(s) are able to communicate, provide feedback, understand and follow instructions during the course of the registry.
• Parent(s) or legal guardian(s) are willing to provide informed consent.

Exclusion Criteria:

• Patient is geographically inaccessible to comply and participate in the registry.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Plagiocephaly; Infants diagnosed with plagiocephaly who have been scanned for a cranial remolding orthosis	Device: MyCRO Band; A 3D-printed cranial remolding orthosis; Device: Traditional CRO; A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband
Brachycephaly; Infants diagnosed with brachycephaly who have been scanned for a cranial remolding orthosis	Device: MyCRO Band; A 3D-printed cranial remolding orthosis; Device: Traditional CRO; A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asymmetry Index	Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly)	Baseline to final follow up visit (est. 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthosis Utilization	Orthosis wear time will be measured from an embedded sensor	Baseline to final follow up visit (est. 6 months)
QUEST 2.0	Quebec User Evaluation of Satisfaction with Assistive Technology 2.0	Final follow up visit (est. 6 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cranial Temperature	Average temperature of the infant's head will be assessed by an embedded temperature sensor	Baseline to final follow up visit (est. 6 months)
Impact of delays on correction of asymmetry	Percent reduction of asymmetry correction when delivery is delayed more than two weeks	Baseline to final follow up visit (est. 6 months)
Duration of therapy	Average amount of time, in months, that the CRO was used	Baseline to final follow up visit (est. 6 months)
Impact of torticollis on compliance	Percent reduction of wear time when torticollis is severe	Baseline to final follow up visit (est. 6 months)
Frequency of additional fittings	Measuring the number of times the orthosis had to be refitted to accommodate changes in head shape	Baseline to final follow up visit (est. 6 months)

Collaborators and Investigators

• Sponsor: Otto Bock HealthCare LP

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: CRO; MyCRO; Cranial Helmet; Cranial Orthosis; Cranial Remolding Orthosis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Synostosis; Dysostoses; Craniosynostoses; Plagiocephaly
• Other Study ID Numbers: OB114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plans have been made to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No