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Completed

NCT Number: NCT05154175

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

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.

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Key information

Conditions

Plagiocephaly, Positional Bone Diseases Bone Diseases, Developmental Brachycephaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Plagiocephaly Plagiocephaly, Nonsynostotic Synostosis

Age range

3 month–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chabloz Orthopédie Annecy, Annecy, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ottobock helmet

Device

Patients treated in current practice

Other names: MyCRO Band

Primary outcomes

  1. Cranial deformation index

    Time frame: 6 weeks

    The cranial deformation index is a ratio (%) of head diameters characterizing head deformation.

Secondary outcomes

  1. Satisfaction of parents regarding the device and the services provided by the orthotist

    Time frame: Through study completion, an average of 6 months

    QUEST 2.0

Sponsors and collaborators

Lead sponsor

Otto Bock France SNC

Industry

Collaborators

  • Quanta Medical

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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