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

NCT05154175 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 452

Last updated 2022-04-12

No results posted yet for this study

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

Interventions

DEVICE

Ottobock helmet

Patients treated in current practice

Sponsors & Collaborators

  • Quanta Medical

    collaborator INDUSTRY

  • Otto Bock France SNC

    lead INDUSTRY

Principal Investigators

  • Hannelore Willenborg, Dr. · Hannover University Hospital Center, Diakovere Annastift, Germany

  • Dorothea Daentzer, Prof.Dr.med. · Hannover University Hospital Center, Diakovere Annastift, Germany

Eligibility

Min Age
3 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-01-15
Completion
2022-01-31
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154175 on ClinicalTrials.gov