FaciocraniosynostosesCRANIORESPNCT01022008
Assessment Study of Faciocraniosynostosis by Craniofacial Osteodistraction
A study testing Osteodistraction techniques in people with Faciocraniosynostoses, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Faciocraniosynostoses
- What is being tested?
- Osteodistraction techniques
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age under 18 years
- faciocraniosynostosis
- surgery indication to craniofacial osteotomies
- informed consent
- social security
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Improvement 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.
Read more
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.
Read the 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.
- Conditions
- Faciocraniosynostoses
- Being tested
- Osteodistraction techniques
- Keywords
- Exorbitism, Upper respiratory airways, Osteodistraction, Polysomnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteodistraction techniquesDevice
Treatment based on craniofacial osteotomies and osteodistraction techniques.
| Study group | Role | What they receive |
|---|---|---|
| Osteodistraction techniques | Experimental | Osteodistraction techniques Receives: Device: Osteodistraction techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of respiratory function
Measured: 6 months and 1 year
Secondary outcomes (2)
Otorhinolaryngology events
Measured: 6 months and one year
Post-surgery infections
Measured: post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FaciocraniosynostosesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Eric Arnaud, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022008
- Sponsor's protocol ID
- K071202
- Acronym
- CRANIORESP
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2009
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Khonsari RH, Haber S, Paternoster G, Fauroux B, Morisseau-Durand MP, Cormier-Daire V, Legeai-Mallet L, James S, Hennocq Q, Arnaud E. The influence of fronto-facial monobloc advancement on obstructive sleep apnea: An assessment of 109 syndromic craniosynostoses cases. J Craniomaxillofac Surg. 2020 Jun;48(6):536-547. doi: 10.1016/j.jcms.2020.04.001. Epub 2020 Apr 13.
PubMed 32354613
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Improvement of Faciocraniosynostosis by Craniofacial Osteodistraction
- ClinicalTrials.gov ID
- NCT01022008
- Acronym / sponsor ID
- CRANIORESP / K071202
- Conditions
- Faciocraniosynostoses
- Keywords
- Exorbitism, Upper respiratory airways, Osteodistraction, Polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2009 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteodistraction techniques | Experimental | Device: Osteodistraction techniquesOsteodistraction techniques |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- age under 18 years
- faciocraniosynostosis
- surgery indication to craniofacial osteotomies
- informed consent
- social security
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteodistraction techniquesTreatment based on craniofacial osteotomies and osteodistraction techniques. | Device | Osteodistraction techniques |
Primary outcome
Improvement of respiratory function
Time frame: 6 months and 1 year
2 secondary outcomes
Otorhinolaryngology events
Time frame: 6 months and one year
Post-surgery infections
Time frame: post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication: PubMed 32354613Khonsari RH, Haber S, Paternoster G, Fauroux B, Morisseau-Durand MP, Cormier-Daire V, Legeai-Mallet L, James S, Hennocq Q, Arnaud E. The influence of fronto-facial monobloc advancement on obstructive sleep apnea: An assessment of 109 syndromic craniosynostoses cases. J Craniomaxillofac Surg. 2020 Jun;48(6):536-547. doi: 10.1016/j.jcms.2020.04.001. Epub 2020 Apr 13.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Arnaud, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteodistraction techniques in people with Faciocraniosynostoses, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of respiratory function (time frame: 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01022008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.