Cranial Remolding Orthosis Registry

Part of paid clinical trials in Madison Heights, Michigan.

Sponsor
Otto Bock HealthCare LP
Study ID
NCT06762691
Status
Not Yet Recruiting

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Conditions

  • Asymmetric Head
  • Brachycephaly
  • Plagiocephaly

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • MyCRO Band — DEVICE
    A 3D-printed cranial remolding orthosis
  • Traditional CRO — DEVICE
    A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband

Study Details

A registry of infants fitted with a cranial remolding orthosis.

Key Dates

Start date
Apr 30, 2025
Status verified
Dec 2024
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Plagiocephaly
    Infants diagnosed with plagiocephaly who have been scanned for a cranial remolding orthosis
  • Arm: Brachycephaly
    Infants diagnosed with brachycephaly who have been scanned for a cranial remolding orthosis

Primary Outcome Measure

Asymmetry Index [ Time Frame: Baseline to final follow up visit (est. 6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wright & FilippisMadison HeightsMichigan48071-

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