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

Maxillo-Facial Surgery Clinical Trial

Official title:

RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery – A Prospective Randomized Trial in Therapeutic Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00240669
• Other study ID #: 2004.366
• Status: Recruiting
• Phase: N/A
• First received: October 14, 2005
• Last updated: April 26, 2007
• Start date: November 2005

Study information

• Verified date: April 2007
• Source: Hospices Civils de Lyon
• Contact: Pierre BOULETREAU, MD
• Phone: 33 4 78 86 19 36
• Email: pierre.bouletreau[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Maxillo-Facial Surgery

Intervention

Device:
• Resorbable device PLLA/PGA

• Titanium device

Locations

Country	Name	City	State
France	Pierre Bouletreau	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of device ergonomy :
Secondary	The operative time of each surgery will be monitored, to compare operative duration of operations ; the only variable will be the osteosynthesis method.
Secondary	Clinical tolerance of the devices
Secondary	pain (Visual Analogic Scale),
Secondary	local inflammation,
Secondary	scar disunion,
Secondary	infection,
Secondary	subcutaneous or submucous palpation of the plates.