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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT00240669

Collaborator

(none)

308

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maxillo-Facial Surgery	Device: Resorbable device PLLA/PGA Device: Titanium device	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pierre Bouletreau	Lyon		France	69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Pierre BOULETREAU, MD, Hospices Civile de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00240669

Other Study ID Numbers:

2004.366

First Posted:

Oct 18, 2005

Last Update Posted:

Apr 27, 2007

Last Verified:

Apr 1, 2007

Keywords provided by , ,

Maxillo facial surgery,

osteosynthesis,

resorbable device

Study Results

No Results Posted as of Apr 27, 2007