Completed

NCT Number: NCT01022008

Assessment Study of Faciocraniosynostosis by Craniofacial Osteodistraction

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.

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Key information

Conditions

Faciocraniosynostoses

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Necker

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Osteodistraction techniques

Device

Treatment based on craniofacial osteotomies and osteodistraction techniques.

Primary outcomes

Improvement of respiratory function

Time frame: 6 months and 1 year

Secondary outcomes

Otorhinolaryngology events

Time frame: 6 months and one year
Post-surgery infections

Time frame: post surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Respiratory Improvement of Faciocraniosynostosis by Craniofacial Osteodistraction

Acronym: CRANIORESP

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Dec 1, 2009
Registry last updated: Mar 5, 2026

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

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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.