Status:
UNKNOWN
RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Maxillo-Facial Surgery
Eligibility:
All Genders
18-50 years
Phase:
NA
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 obj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00240669
Start Date
November 1 2005
Last Update
April 27 2007
Active Locations (1)
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1
Pierre Bouletreau
Lyon, France, 69495