Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both

Plagiocephaly, Nonsynostotic Clinical Trial

Official title:

Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both and Parents' Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154175
• Other study ID #: BP-11-PT006-FR-01-2108
• Status: Completed
• Start date: November 15, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Otto Bock France SNC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: January 31, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 2 Years

Eligibility

Inclusion Criteria:

• Infant with positional cranial deformation

• Infant treated with an Ottobock helmet between May 1st, 2020 and May 1st, 2021

Exclusion Criteria:

• Patient whose parents (or legal guardians) disagree to participate in the study.

• Patient whose parents (or legal guardians) are unable to understand or answer the questionnaire.

Related Conditions & MeSH terms

• Brachycephaly
• Craniosynostoses
• Plagiocephaly
• Plagiocephaly, Nonsynostotic
• Plagiocephaly, Positional

Intervention

Device:
• Ottobock helmet
Patients treated in current practice

Locations

Country	Name	City	State
France	Chabloz Orthopédie Annecy	Annecy
France	Orthèse Prothèse Changeant OPC	Castelnau-le-Lez
France	Chabloz Orthopédie Clermont-Ferrand	Cournon-d'Auvergne
France	Technic'Ortho	Lay-Saint-Christophe
France	Chabloz Orthopédie Nice	Nice
France	Chabloz Orthopédie Lyon	Oullins
France	Orthèses Prothèses Générales OPG	Paris
France	Chabloz Orthopédie Valence	Portes-lès-Valence
France	Chabloz Orthopédie Dijon	Saint-Apollinaire
France	Chabloz Orthopédie Grenoble	Seyssinet-Pariset
France	Chabloz Orthopédie Toulouse	Toulouse
France	Chabloz Orthopédie Venelles	Venelles

Sponsors (2)

Lead Sponsor	Collaborator
Otto Bock France SNC	Quanta Medical

Country where clinical trial is conducted

France, 

References & Publications (38)

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Wilbrand JF, Schmidtberg K, Bierther U, Streckbein P, Pons-Kuehnemann J, Christophis P, Hahn A, Schaaf H, Howaldt HP. Clinical classification of infant nonsynostotic cranial deformity. J Pediatr. 2012 Dec;161(6):1120-5. doi: 10.1016/j.jpeds.2012.05.023. Epub 2012 Jun 23. — View Citation

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cranial deformation index	The cranial deformation index is a ratio (%) of head diameters characterizing head deformation.	6 weeks
Secondary	Satisfaction of parents regarding the device and the services provided by the orthotist	QUEST 2.0	Through study completion, an average of 6 months