Overview

This trial is active, not recruiting.

Condition faciocraniosynostoses
Treatment osteodistraction techniques
Sponsor Assistance Publique - Hôpitaux de Paris
Start date September 2009
End date September 2014
Trial size 25 participants
Trial identifier NCT01022008, K071202

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Osteodistraction techniques
osteodistraction techniques Osteodistraction techniques
Treatment based on craniofacial osteotomies and osteodistraction techniques.

Primary Outcomes

Measure
Improvement of respiratory function
time frame: 6 months and 1 year

Secondary Outcomes

Measure
Otorhinolaryngology events
time frame: 6 months and one year
Post-surgery infections
time frame: post surgery

Eligibility Criteria

Male or female participants up to 18 years old.

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

Additional Information

Official title Respiratory Improvement of Faciocraniosynostosis by Craniofacial Osteodistraction
Principal investigator Eric Arnaud, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.