An observational study in Plagiocephaly, Positional, Plagiocephaly, Nonsynostotic and Brachycephaly, sponsored by Otto Bock France SNC. Completed at 12 sites in France. Open to participants aged 3 Months to 2 Years. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Otto Bock France SNC · Observational
The objective of the research is to measure the effectiveness of the Ottobock helmet, an innovative 3D-printed cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both.
This research is a retrospective multi-centric study composed of a collection of clinical data from orthotists database and a survey for patient's parents.
The Ottobock helmet is a cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both. This medical device is a 3D-printed helmet, with an elastic closing system which allow the head growth, maintain a constant pressure in the helmet and ensure a good adjustment.
Even though there is an effectiveness observed, there are no existing clinical evidences on this type of helmet so far, and there is a need to conduct a research on a large number of patients to measure the effectiveness and describe the population treated. This study will give more information to health professionals (doctors, orthopedic technicians, etc.) and health authorities, about the benefits of the orthopedic treatment of the positional cranial deformations in infants.
The study is composed of an electronic case report form (eCRF) to be fulfilled by the orthotists and an electronic questionnaire (ePRO) to be fulfilled by the patient's parents. The electronic questionnaires, data treatment and analysis are handled by a Contract Research Organization (CRO).
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 452 is above the median of 43 across 26 observational studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →Otto Bock France SNC is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is composed of infants who have been fitted with an Ottobock helmet to treat their positional cranial deformation: plagiocephaly, brachycephaly or a combination of these two deformations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Infants treated with an Ottobock helmet
Device: Ottobock helmet
Patients treated in current practice
Also known as: MyCRO Band
Cranial deformation index
The cranial deformation index is a ratio (%) of head diameters characterizing head deformation.
Time frame: 6 weeks
Satisfaction of parents regarding the device and the services provided by the orthotist
QUEST 2.0
Time frame: Through study completion, an average of 6 months
Plan to share: Undecided
Ran from Nov 2021 to primary completion in Jan 2022, 2 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Otto Bock France SNC