RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery

Study Overview
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Brief Summary
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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.

Official Title
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RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery - A Prospective Randomized Trial in Therapeutic Strategy

Conditions
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Maxillo-Facial Surgery

Intervention / Treatment
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* Device: Resorbable device PLLA/PGA
* Device: Titanium device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Resorbable device PLLA/PGA|nan|
|Device: Titanium device|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of device ergonomy : |  |  | 
| 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), |  |  | 
| local inflammation, |  |  | 
| scar disunion, |  |  | 
| infection, |  |  | 
| subcutaneous or submucous palpation of the plates. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maxillo facial surgery,, osteosynthesis,, resorbable device