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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plagiocephaly | Infants diagnosed with plagiocephaly who have been scanned for a cranial remolding orthosis |
| |
| Brachycephaly | Infants diagnosed with brachycephaly who have been scanned for a cranial remolding orthosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyCRO Band | Device | A 3D-printed cranial remolding orthosis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Asymmetry Index | Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly) | Baseline to final follow up visit (est. 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Orthosis Utilization | Orthosis wear time will be measured from an embedded sensor | Baseline to final follow up visit (est. 6 months) |
| QUEST 2.0 | Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 |
| Measure | Description | Time Frame |
|---|---|---|
| Cranial Temperature | Average temperature of the infant's head will be assessed by an embedded temperature sensor | Baseline to final follow up visit (est. 6 months) |
| Impact of delays on correction of asymmetry |
Inclusion Criteria:
Exclusion Criteria:
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All infants who have been scanned and fitted with a cranial remolding orthosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jared Howell | Contact | 8328644322 | jared.howell@ottobock.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright & Filippis | Madison Heights | Michigan | 48071 | United States |
No plans have been made to share IPD
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| ID | Term |
|---|---|
| D059041 | Plagiocephaly |
| D003398 | Craniosynostoses |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
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| Traditional CRO |
| Device |
A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband |
|
| Final follow up visit (est. 6 months) |
Percent reduction of asymmetry correction when delivery is delayed more than two weeks
| Baseline to final follow up visit (est. 6 months) |
| Duration of therapy | Average amount of time, in months, that the CRO was used | Baseline to final follow up visit (est. 6 months) |
| Impact of torticollis on compliance | Percent reduction of wear time when torticollis is severe | Baseline to final follow up visit (est. 6 months) |
| Frequency of additional fittings | Measuring the number of times the orthosis had to be refitted to accommodate changes in head shape | Baseline to final follow up visit (est. 6 months) |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |