Cranial Remolding Orthosis Registry

Otto Bock HealthCare LP

Status: Not yet enrolling

Conditions: Plagiocephaly; Asymmetric Head; Brachycephaly

Treatments: Device: Traditional CRO; Device: MyCRO Band

Study type: Observational

Funder types: Industry

Identifiers

NCT06762691

OB114

Details and patient eligibility

About

A registry of infants fitted with a cranial remolding orthosis.

Full description

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

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Plagiocephaly

Description:

Infants diagnosed with plagiocephaly who have been scanned for a cranial remolding orthosis

Treatment:

Device: MyCRO Band

Device: Traditional CRO

Brachycephaly

Description:

Infants diagnosed with brachycephaly who have been scanned for a cranial remolding orthosis

Treatment:

Device: MyCRO Band

Device: Traditional CRO