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

Hospices Civils de Lyon308 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

308

Conditions

Maxillo-Facial Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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.