Maxillo-Facial Surgery Clinical Trial
Official title:
RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery – A Prospective Randomized Trial in Therapeutic Strategy
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
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| Recruiting |
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