NCT05154175

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 452 (actual)
• Sponsor: Otto Bock France SNC · Industry
• Sex: All
• Age: 3 Months – 2 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Plagiocephaly, Positional
• Plagiocephaly, Nonsynostotic
• Brachycephaly

Interventions

Type	Name	Description
DEVICE	Ottobock helmet	Patients treated in current practice

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-01-15
• Completion: 2022-01-31
• First posted: 2021-12-10
• Last updated: 2022-04-12

Locations

12 sites across 1 country: France

Regulatory

• FDA-regulated device study