Cranial Remolding Orthosis Registry

N/ANot Yet RecruitingNCT06762691

Otto Bock HealthCare LP500 enrolled

Overview

A registry of infants fitted with a cranial remolding orthosis.

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

500

Conditions

Plagiocephaly Brachycephaly Asymmetric Head

Interventions

MyCRO BandDEVICE

A 3D-printed cranial remolding orthosis

Traditional CRODEVICE

A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Wright & Filippis

Madison Heights, Michigan, United States

Outcomes

Primary Outcomes

Asymmetry Index

Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly)

Time frame: Baseline to final follow up visit (est. 6 months)

Secondary Outcomes

Orthosis Utilization

Orthosis wear time will be measured from an embedded sensor

Time frame: Baseline to final follow up visit (est. 6 months)

QUEST 2.0

Quebec User Evaluation of Satisfaction with Assistive Technology 2.0

Time frame: Final follow up visit (est. 6 months)

Central Contacts

Jared Howell

CONTACT

8328644322 jared.howell@ottobock.com

Data from ClinicalTrials.gov

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