Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both
NCT ID: NCT05154175
Last Updated: 2022-04-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
452 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-11-15
Study Completion Date
2022-01-31
Brief Summary
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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.
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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Detailed Description
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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).
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
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Plagiocephaly, Positional
Plagiocephaly, Nonsynostotic
Brachycephaly
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
RETROSPECTIVE
Study Groups
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Ottobock helmet
Infants treated with an Ottobock helmet
Ottobock helmet
Intervention Type
DEVICE
Patients treated in current practice
Interventions
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Ottobock helmet
Patients treated in current practice
Intervention Type
DEVICE
Other Intervention Names
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MyCRO Band
Eligibility Criteria
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Inclusion Criteria
* Infant with positional cranial deformation
* Infant treated with an Ottobock helmet between May 1st, 2020 and May 1st, 2021
* 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.
* Patient whose parents (or legal guardians) are unable to understand or answer the questionnaire.
Minimum Eligible Age
3 Months
Maximum Eligible Age
2 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Quanta Medical
INDUSTRY
Sponsor Role
collaborator
Otto Bock France SNC
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hannelore Willenborg, Dr.
Role: STUDY_CHAIR
Hannover University Hospital Center, Diakovere Annastift, Germany
Dorothea Daentzer, Prof.Dr.med.
Role: STUDY_CHAIR
Hannover University Hospital Center, Diakovere Annastift, Germany
Locations
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Chabloz Orthopédie Annecy
Annecy, , France
Site Status
Orthèse Prothèse Changeant OPC
Castelnau-le-Lez, , France
Site Status
Chabloz Orthopédie Clermont-Ferrand
Cournon-d'Auvergne, , France
Site Status
Technic'Ortho
Lay-Saint-Christophe, , France
Site Status
Chabloz Orthopédie Nice
Nice, , France
Site Status
Chabloz Orthopédie Lyon
Oullins, , France
Site Status
Orthèses Prothèses Générales OPG
Paris, , France
Site Status
Chabloz Orthopédie Valence
Portes-lès-Valence, , France
Site Status
Chabloz Orthopédie Dijon
Saint-Apollinaire, , France
Site Status
Chabloz Orthopédie Grenoble
Seyssinet-Pariset, , France
Site Status
Chabloz Orthopédie Toulouse
Toulouse, , France
Site Status
Chabloz Orthopédie Venelles
Venelles, , France
Site Status
Countries
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France
References
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Kelly KM, Joganic EF, Beals SP, Riggs JA, McGuire MK, Littlefield TR. Helmet Treatment of Infants With Deformational Brachycephaly. Glob Pediatr Health. 2018 Oct 16;5:2333794X18805618. doi: 10.1177/2333794X18805618. eCollection 2018.
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BACKGROUND
Hinken L, Willenborg H, Davila LA, Daentzer D. Outcome analysis of molding helmet therapy using a classification for differentiation between plagiocephaly, brachycephaly and combination of both. J Craniomaxillofac Surg. 2019 May;47(5):720-725. doi: 10.1016/j.jcms.2019.01.011. Epub 2019 Jan 17.
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BACKGROUND
Schaaf H, Malik CY, Streckbein P, Pons-Kuehnemann J, Howaldt HP, Wilbrand JF. Three-dimensional photographic analysis of outcome after helmet treatment of a nonsynostotic cranial deformity. J Craniofac Surg. 2010 Nov;21(6):1677-82. doi: 10.1097/SCS.0b013e3181f3c630.
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Wilbrand JF, Wilbrand M, Pons-Kuehnemann J, Blecher JC, Christophis P, Howaldt HP, Schaaf H. Value and reliability of anthropometric measurements of cranial deformity in early childhood. J Craniomaxillofac Surg. 2011 Jan;39(1):24-9. doi: 10.1016/j.jcms.2010.03.010. Epub 2010 Apr 24.
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Purnell CA, Benz AW, Gosain AK. Assessment of Head Shape by Craniofacial Teams: Structuring Practice Parameters to Optimize Efficiency. J Craniofac Surg. 2015 Sep;26(6):1808-11. doi: 10.1097/SCS.0000000000001948.
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Steinberg JP, Rawlani R, Humphries LS, Rawlani V, Vicari FA. Effectiveness of conservative therapy and helmet therapy for positional cranial deformation. Plast Reconstr Surg. 2015 Mar;135(3):833-842. doi: 10.1097/PRS.0000000000000955.
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Graham T, Adams-Huet B, Gilbert N, Witthoff K, Gregory T, Walsh M. Effects of Initial Age and Severity on Cranial Remolding Orthotic Treatment for Infants with Deformational Plagiocephaly. J Clin Med. 2019 Jul 24;8(8):1097. doi: 10.3390/jcm8081097.
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van Wijk RM, van Vlimmeren LA, Groothuis-Oudshoorn CG, Van der Ploeg CP, Ijzerman MJ, Boere-Boonekamp MM. Helmet therapy in infants with positional skull deformation: randomised controlled trial. BMJ. 2014 May 1;348:g2741. doi: 10.1136/bmj.g2741.
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Picart T, Beuriat PA, Szathmari A, Di Rocco F, Mottolese C. Positional cranial deformation in children: A plea for the efficacy of the cranial helmet in children. Neurochirurgie. 2020 Apr;66(2):102-109. doi: 10.1016/j.neuchi.2019.10.011. Epub 2020 Jan 17.
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Lee HS, Kim SJ, Kwon JY. Parents' Perspectives and Clinical Effectiveness of Cranial-Molding Orthoses in Infants With Plagiocephaly. Ann Rehabil Med. 2018 Oct;42(5):737-747. doi: 10.5535/arm.2018.42.5.737. Epub 2018 Oct 31.
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Other Identifiers
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BP-11-PT006-FR-01-2108
Identifier Type: -
Identifier Source: org_study_id
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