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

NCT05154175 | Completed FDA Device

• 1 other identifier: BP-11-PT006-FR-01-2108
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 12

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.

Conditions

Plagiocephaly, Positional; Plagiocephaly, Nonsynostotic; Brachycephaly

Keywords

Cranial orthosis; Helmet treatment

Outcome Measures

Primary Outcomes (1)

• Cranial deformation index

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

  6 weeks

Secondary Outcomes (1)

• Satisfaction of parents regarding the device and the services provided by the orthotist

  Through study completion, an average of 6 months

Study Arms (1)

Ottobock helmet

Infants treated with an Ottobock helmet

Device: Ottobock helmet

Interventions

Ottobock helmet DEVICE

Patients treated in current practice

Also known as: MyCRO Band

Ottobock helmet

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otto Bock France SNC: lead
• Quanta Medical: collaborator

Study Sites (12)

Chabloz Orthopédie Annecy

Annecy, France

Location

Orthèse Prothèse Changeant OPC

Castelnau-le-Lez, France

Location

Chabloz Orthopédie Clermont-Ferrand

Cournon-d'Auvergne, France

Location

Technic'Ortho

Lay-Saint-Christophe, France

Location

Chabloz Orthopédie Nice

Nice, France

Location

Chabloz Orthopédie Lyon

Oullins, France

Location

Orthèses Prothèses Générales OPG

Paris, France

Location

Chabloz Orthopédie Valence

Portes-lès-Valence, France

Location

Chabloz Orthopédie Dijon

Saint-Apollinaire, France

Location

Chabloz Orthopédie Grenoble

Seyssinet-Pariset, France

Location

Chabloz Orthopédie Toulouse

Toulouse, France

Location

Chabloz Orthopédie Venelles

Venelles, France

Location

Related Publications (38)

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MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic; Craniosynostoses

Condition Hierarchy (Ancestors)

Plagiocephaly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases

Study Officials

• Hannelore Willenborg, Dr.

  Hannover University Hospital Center, Diakovere Annastift, Germany

  STUDY CHAIR

• Dorothea Daentzer, Prof.Dr.med.

  Hannover University Hospital Center, Diakovere Annastift, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 10, 2021
• Study Start: November 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: January 31, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

FR (12)