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Assessment Study of Faciocraniosynostosis by Craniofacial Osteodistraction (CRANIORESP)

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ClinicalTrials.gov Identifier: NCT01022008
Recruitment Status : Unknown
Verified April 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : December 1, 2009
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Context. Faciocraniosynostoses present with an insufficient growth of the craniofacial skeleton due to premature fusion of skull and facial sutures. There are prenatal conditions with functional (risk of raised intracranial pressure) and morphological consequences (exorbitism, and impairment of upper respiratory airways), the severity of which justifies an early surgical treatment based on craniofacial osteotomies and osteodistraction techniques.

Distraction techniques were started in our unit eleven years ago, and never ceased to be modified: Recent improvements allowed better correction of exorbitism and therefore reduction of visual risks. But the improvements of the respiratory function remain insufficient. The initial evaluations of the respiratory functions were based on blood oxygenation monitoring, and showed real improvement. But we have routinely screened our patients with complete polysomnography examinations for the past year, and this has always revealed the existence of severe sleep apnea syndromes that we fail to correct completely, although there were slightly improved.

The aim of this PHRC protocol is :

  • the qualitative and quantitative improvement of the respiratory status with a reinforced task force group including the specialists in genuine multidisciplinary approach.
  • A modification of the surgical technique including modifications of the existing distraction devices, an increased number of implanted devices, and maybe a change in the surgical strategy.

Condition or disease Intervention/treatment Phase
Faciocraniosynostoses Device: Osteodistraction techniques Not Applicable

Detailed Description:

Study design. This is a monocentric study, the patient being its own control. Due to the extremely low incidence of these conditions, it is foreseen to include twelve patients per year, during two years, which represent 24 patients in total with a minimum follow-up of one year.

Evaluation criteria. The main evaluation criteria are the polysomnography variables (sleep apnea index, characterization of obstructive versus central respiratory events, the oxygenation pattern through the night), which will be performed before and after surgery (6 and 12 months post-op). The secondary criteria are the exorbitism correction analysed with the globe protrusion index and the rate of infections. A multidisciplinary task force group has already been structured in Necker Hospital.

Expected results. We expect to analyze and correct all the sleep apnea syndromes. Many modifications could be made on the distractors, including removal of the activation rods, bioresorbable parts, as well as the modification of the surgical techniques.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Respiratory Improvement of Faciocraniosynostosis by Craniofacial Osteodistraction
Study Start Date : September 2009
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Osteodistraction techniques
Osteodistraction techniques
Device: Osteodistraction techniques
Treatment based on craniofacial osteotomies and osteodistraction techniques.




Primary Outcome Measures :
  1. Improvement of respiratory function [ Time Frame: 6 months and 1 year ]

Secondary Outcome Measures :
  1. Otorhinolaryngology events [ Time Frame: 6 months and one year ]
  2. Post-surgery infections [ Time Frame: post surgery ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age under 18 years
  • faciocraniosynostosis
  • surgery indication to craniofacial osteotomies
  • informed consent
  • social security

Exclusion Criteria:

  • no possibilities of follow-up during one year post-surgery
  • history of radiotherapy
  • acquired or hereditary immunodeficiency syndromes
  • mental retardation
  • bone conditions could not support distractors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022008


Locations
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France
Hopital Necker
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Eric Arnaud, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01022008     History of Changes
Other Study ID Numbers: K071202
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Exorbitism
Upper respiratory airways
Osteodistraction
Polysomnography