NCT06762691

Brief Summary

A registry of infants fitted with a cranial remolding orthosis.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2025Apr 2030

First Submitted

Initial submission to the registry

December 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

January 7, 2025

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

December 31, 2024

Last Update Submit

December 31, 2024

Conditions

PlagiocephalyBrachycephalyAsymmetric Head

Keywords

CROMyCROCranial HelmetCranial OrthosisCranial Remolding Orthosis

Outcome Measures

Primary Outcomes (1)

  • Asymmetry Index

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

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

Secondary Outcomes (2)

  • Orthosis Utilization

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

  • QUEST 2.0

    Final follow up visit (est. 6 months)

Other Outcomes (5)

  • Cranial Temperature

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

  • Impact of delays on correction of asymmetry

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

  • Duration of therapy

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

  • +2 more other outcomes

Study Arms (2)

Plagiocephaly

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

Device: MyCRO BandDevice: Traditional CRO

Brachycephaly

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

Device: MyCRO BandDevice: Traditional CRO

Interventions

MyCRO BandDEVICE

A 3D-printed cranial remolding orthosis

BrachycephalyPlagiocephaly
Traditional CRODEVICE

A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband

BrachycephalyPlagiocephaly

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wright & Filippis

Madison Heights, Michigan, 48071, United States

Location

MeSH Terms

Conditions

PlagiocephalyCraniosynostoses

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSynostosisDysostosesBone Diseases, DevelopmentalBone Diseases

Central Study Contacts

Jared Howell

CONTACT

8328644322jared.howell@ottobock.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 7, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Last Updated

January 7, 2025

Record last verified: 2024-12

Locations

US(1)