Clinical trial NCT05154175: Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both
Official title: Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both and Parents' Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plagiocephaly, Positional
Plagiocephaly, Nonsynostotic
Brachycephaly
Keywords: Cranial orthosis
Helmet treatment
Lead sponsor: Otto Bock France SNC
Sponsor class: INDUSTRY
Collaborators: name: Quanta Medical
First posted: 2021-12-10
Enrollment: 452
Sex: ALL
Minimum age (years): 3
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Cranial deformation index
timeFrame: 6 weeks
Secondary outcomes:
measure: Satisfaction of parents regarding the device and the services provided by the orthotist
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Chabloz Orthopédie Annecy
city: Castelnau-le-Lez
country: France
facility: Orthèse Prothèse Changeant OPC
city: Cournon-d'Auvergne
country: France
facility: Chabloz Orthopédie Clermont-Ferrand
city: Lay-Saint-Christophe
country: France
facility: Technic'Ortho
city: Nice
country: France
facility: Chabloz Orthopédie Nice
city: Oullins
country: France
facility: Chabloz Orthopédie Lyon
city: Paris
country: France
facility: Orthèses Prothèses Générales OPG
city: Portes-lès-Valence
country: France
facility: Chabloz Orthopédie Valence
city: Saint-Apollinaire
country: France
facility: Chabloz Orthopédie Dijon
city: Seyssinet-Pariset
country: France
facility: Chabloz Orthopédie Grenoble
city: Toulouse
country: France
facility: Chabloz Orthopédie Toulouse
city: Venelles
country: France
facility: Chabloz Orthopédie Venelles
Study officials:
affiliation: Hannover University Hospital Center, Diakovere Annastift, Germany
name: Hannelore Willenborg, Dr.
role: STUDY_CHAIR
affiliation: Hannover University Hospital Center, Diakovere Annastift, Germany
name: Dorothea Daentzer, Prof.Dr.med.
role: STUDY_CHAIR
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