Maxillo-Facial Surgery
Conditions
Keywords
Maxillo facial surgery,, osteosynthesis,, resorbable device
Brief summary
Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates. 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.
Interventions
DEVICEResorbable device PLLA/PGA
DEVICETitanium device
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18\<Age\<50. * 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
* Any previous surgery at the same operative site. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA will be evaluated by the notion of unperfect resuts. | — |
Secondary
| Measure | Time frame |
|---|---|
| The operative time of each surgery will be monitored, to compare operative duration of operations ; the only variable will be the osteosynthesis method. | — |
| Clinical tolerance of the devices | — |
| pain (Visual Analogic Scale), | — |
| Evaluation of device ergonomy : | — |
| scar disunion, | — |
| infection, | — |
| subcutaneous or submucous palpation of the plates. | — |
| local inflammation, | — |
Countries
France
Contacts
Primary ContactPierre BOULETREAU, MD
Outcome results
None listed