Clinical trial NCT00240669: RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery
Official title: RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery - A Prospective Randomized Trial in Therapeutic Strategy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillo-Facial Surgery
Keywords: Maxillo facial surgery,
osteosynthesis,
resorbable device
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-10-18
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Evaluation of device ergonomy :
measure: The operative time of each surgery will be monitored, to compare operative duration of operations ; the only variable will be the osteosynthesis method.
measure: Clinical tolerance of the devices
measure: pain (Visual Analogic Scale),
measure: local inflammation,
measure: scar disunion,
measure: infection,
measure: subcutaneous or submucous palpation of the plates.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pierre Bouletreau
Study officials:
affiliation: Hospices Civile de Lyon
name: Pierre BOULETREAU, MD
role: PRINCIPAL_INVESTIGATOR
References: