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

Otto Bock Healthcare (Ottobock)

Status: Completed

Conditions: Brachycephaly; Plagiocephaly, Nonsynostotic; Plagiocephaly, Positional

Treatments: Device: Ottobock helmet

Study type: Observational

Funder types: Industry

Identifiers

NCT05154175

BP-11-PT006-FR-01-2108

Details and patient eligibility

About

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.

Full 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).

Enrollment: 452 patients

Sex: All

Ages: 3 months to 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

452 participants in 1 patient group

Ottobock helmet

Description:

Infants treated with an Ottobock helmet

Treatment:

Device: Ottobock helmet