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

Civil Hospices of Lyon

Status: Unknown

Conditions: Maxillo-Facial Surgery

Treatments: Device: Resorbable device PLLA/PGA; Device: Titanium device

Study type: Interventional

Funder types: Other

Identifiers

NCT00240669

2004.366

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18<Age<50.
• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)