RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery
Recruitment status was: Recruiting
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.
Device: Resorbable device PLLA/PGA
Device: Titanium device
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery – A Prospective Randomized Trial in Therapeutic Strategy|
- 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.
- 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,
- subcutaneous or submucous palpation of the plates.
|Study Start Date:||November 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240669
|Lyon, France, 69495|
|Principal Investigator:||Pierre BOULETREAU, MD||Hospices Civile de Lyon|