Cranial Remolding Orthosis Registry

Not yet recruiting

• Conditions: Plagiocephaly; Brachycephaly; Asymmetric Head

• Registration Number: NCT06762691
• Lead Sponsor: Otto Bock HealthCare LP

Brief Summary

A registry of infants fitted with a cranial remolding orthosis.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Last Update Submitted: 2024-12-31
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Study Start: 2025-04
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asymmetry Index	Baseline to final follow up visit (est. 6 months)	Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wright & Filippis; 🇺🇸 Madison Heights, Michigan, United States