RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery - A Prospective Randomized Trial in Therapeutic Strategy
试验速览
- 阶段
- 不适用
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18<Age<
- •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.
排除标准
- •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.
结局指标
主要结局
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.
次要结局
- 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.