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

2014-07-23 21:47:24 | BioPortfolio

Summary

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 Design

Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Maxillo-Facial Surgery

Intervention

Resorbable device PLLA/PGA, Titanium device

Location

Pierre Bouletreau
Lyon
France
69495

Status

Recruiting

Source

Hospices Civils de Lyon

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:47:24-0400

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