Assessment Study of Faciocraniosynostosis by Craniofacial Osteodistraction

2014-08-27 03:17:39 | BioPortfolio


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.


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.

Study Design

Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label




Osteodistraction techniques


Hopital Necker




Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:17:39-0400

Clinical Trials [122 Associated Clinical Trials listed on BioPortfolio]

Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain

This Protocol is intended to facilitate development and testing of new techniques for functional MRI by UC Davis Research Faculty, as well as to facilitate the evaluation of new techniques...

Comparison Between Two Tissue Acquisition Techniques by Endoscopic Ultrasound. (EUS)

There are various techniques to obtain tissue samples by using fine needle guided by endoscopic ultrasound (EUS). These techniques attempt to obtain the most adequate material with the bes...

Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques

To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.

Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants

This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (...

Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity an...

PubMed Articles [4429 Associated PubMed Articles listed on BioPortfolio]

Techniques for Investigating the Anatomy of the Ant Visual System.

This article outlines a suite of techniques in light microscopy (LM) and electron microscopy (EM) which can be used to study the internal and external eye anatomy of insects. These include traditional...

Management of the Cleft Nasal Tip: An Overview of Classic Techniques and Strategies.

The challenges of cleft reconstruction have been present for centuries. However, understanding of the cleft nasal tip and the evolution of techniques decidedly began in the 20th century and refinement...

Microalgae harvesting techniques: A review.

Microalgae with wide range of commercial applications have attracted a lot of attention of the researchers in the last few decades. However, microalgae utilization is not economically sustainable due ...

Reported credibility techniques in higher education evaluation studies that use qualitative methods: A research synthesis.

This synthesis study examined the reported use of credibility techniques in higher education evaluation articles that use qualitative methods. The sample included 118 articles published in six leading...

The Current Status of Peer Assessment Techniques and Sociometric Methods.

Current issues in the use of peer assessment techniques and sociometric methods are discussed. Attention is paid to the contributions of the four articles in this volume. Together these contributions ...

Medical and Biotech [MESH] Definitions

Investigative techniques used in pre-clinical and clinical research, epidemiology, chemistry, immunology, genetics, etc. They do not include techniques specifically applied to DIAGNOSIS; THERAPEUTICS; anesthesia and analgesia; SURGICAL PROCEDURES, OPERATIVE; and DENTISTRY.

Methods pertaining to the generation of new individuals, including techniques used in selective BREEDING, cloning (CLONING, ORGANISM), and assisted reproduction (REPRODUCTIVE TECHNIQUES, ASSISTED).

Techniques for controlling bleeding.

Techniques used in studying bacteria.

Clinical and laboratory techniques used to enhance fertility in humans and animals.

More From BioPortfolio on "Assessment Study of Faciocraniosynostosis by Craniofacial Osteodistraction"

Quick Search


Relevant Topic

Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Searches Linking to this Trial