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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00240669
First received: October 14, 2005
Last updated: April 26, 2007
Last verified: April 2007
  Purpose

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 Intervention
Maxillo-Facial Surgery
Device: Resorbable device PLLA/PGA
Device: Titanium device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Hospices Civils de Lyon:

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.

Estimated Enrollment: 308
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240669

Contacts
Contact: Pierre BOULETREAU, MD 33 4 78 86 19 36 pierre.bouletreau@chu-lyon.fr

Locations
France
Pierre Bouletreau Recruiting
Lyon, France, 69495
Contact: Pierre BOULETREAU, MD    33 4 78 86 19 36    pierre.bouletreau@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Pierre BOULETREAU, MD Hospices Civile de Lyon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00240669     History of Changes
Other Study ID Numbers: 2004.366
Study First Received: October 14, 2005
Last Updated: April 26, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Maxillo facial surgery,
osteosynthesis,
resorbable device

ClinicalTrials.gov processed this record on September 30, 2014