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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.
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.
Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Resorbable device PLLA/PGA, Titanium device
Hospices Civils de Lyon
Published on BioPortfolio: 2014-07-23T21:47:24-0400
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Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Device designed to wear externally to support muscular skeletal system in various movements such as RANGE OF MOTIONS; WEIGHT-BEARING; GAIT; and LOCOMOTION.
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
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