RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00240669|
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : October 18, 2005
Last Update Posted : April 27, 2007
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.
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||308 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery – A Prospective Randomized Trial in Therapeutic Strategy|
|Study Start Date :||November 2005|
- 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.
- 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,
- subcutaneous or submucous palpation of the plates.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240669
|Contact: Pierre BOULETREAU, MD||33 4 78 86 19 firstname.lastname@example.org|
|Lyon, France, 69495|
|Contact: Pierre BOULETREAU, MD 33 4 78 86 19 36 email@example.com|
|Principal Investigator:||Pierre BOULETREAU, MD||Hospices Civile de Lyon|