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NCT Number: NCT06762691

Cranial Remolding Orthosis Registry

A registry of infants fitted with a cranial remolding orthosis.

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Key information

Conditions

Plagiocephaly Asymmetric Head Bone Diseases Bone Diseases, Developmental Brachycephaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Synostosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Wright & Filippis

Madison Heights, Michigan, 48071, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MyCRO Band

Device

A 3D-printed cranial remolding orthosis

Traditional CRO

Device

A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband

Primary outcomes

  1. Asymmetry Index

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

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

Secondary outcomes

  1. Orthosis Utilization

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

    Orthosis wear time will be measured from an embedded sensor

  2. QUEST 2.0

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

    Quebec User Evaluation of Satisfaction with Assistive Technology 2.0

Other outcomes

  1. Cranial Temperature

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

    Average temperature of the infant's head will be assessed by an embedded temperature sensor

  2. Impact of delays on correction of asymmetry

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

    Percent reduction of asymmetry correction when delivery is delayed more than two weeks

  3. Duration of therapy

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

    Average amount of time, in months, that the CRO was used

  4. Impact of torticollis on compliance

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

    Percent reduction of wear time when torticollis is severe

  5. Frequency of additional fittings

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

    Measuring the number of times the orthosis had to be refitted to accommodate changes in head shape

Study contacts

Contact information is provided by the study sponsor or research team.

Jared Howell

CONTACT

[email protected]

8328644322

Sponsors and collaborators

Lead sponsor

Otto Bock HealthCare LP

Industry

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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