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

Civil Hospices of Lyon logo

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)

Trial contacts and locations

1

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Central trial contact

Pierre BOULETREAU, MD

Data sourced from clinicaltrials.gov

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