RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery
NCT ID: NCT00240669
Last Updated: 2007-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
308 participants
INTERVENTIONAL
2005-11-30
Brief Summary
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Secondary objective :
* To evaluate the resorbable device ergonomy versus Titanium.
* To evaluate the clinical tolerance of resorbable device versus Titanium.
Hypothesis :
Osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with Titanium, with a less important probability of re-operation.
Study duration : 14 months for each patient.
Study treatment :
* Group I : Resorbable device PLLA/PGA.
* Group II : Titanium device.
Study visits :
\- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14.
Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Resorbable device PLLA/PGA
Titanium device
Eligibility Criteria
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Inclusion Criteria
* One or more fractures of facial massif requiring a surgical setting with osteosynthesis plates.
* One or more osteotomy of facial massif requiring a surgical setting with osteosynthesis plates.
* Orally and written informed patient. Patient willing to participate the study.
* Signed informed consent.
Exclusion Criteria
* Patient suffering from chronic affection which could interfere with bone consolidation.
* Corticotherapy, immunosuppressive or anticonvulsant treatment or long term antibiotherapy.
* Nursing or pregnant female.
* Patient with a high risk of non compliance to sudy visits.
* Unconscious patient.
18 Years
50 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Principal Investigators
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Pierre BOULETREAU, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civile de Lyon
Locations
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Pierre Bouletreau
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Pierre BOULETREAU, MD
Role: primary
Other Identifiers
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2004.366
Identifier Type: -
Identifier Source: org_study_id