Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT00240669
Status:
UNKNOWN
Last Update Posted:
2007-04-27
First Post:
2005-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 308}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-26', 'studyFirstSubmitDate': '2005-10-14', 'studyFirstSubmitQcDate': '2005-10-14', 'lastUpdatePostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of device ergonomy :'}, {'measure': 'The operative time of each surgery will be monitored, to compare operative duration of operations ; the only variable will be the osteosynthesis method.'}, {'measure': 'Clinical tolerance of the devices'}, {'measure': 'pain (Visual Analogic Scale),'}, {'measure': 'local inflammation,'}, {'measure': 'scar disunion,'}, {'measure': 'infection,'}, {'measure': 'subcutaneous or submucous palpation of the plates.'}]}, 'conditionsModule': {'keywords': ['Maxillo facial surgery,', 'osteosynthesis,', 'resorbable device'], 'conditions': ['Maxillo-Facial Surgery']}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary objective :\n\n* To evaluate the resorbable device ergonomy versus Titanium.\n* To evaluate the clinical tolerance of resorbable device versus Titanium.\n\nHypothesis :\n\nOsteosynthesis 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.\n\nStudy duration : 14 months for each patient.\n\nStudy treatment :\n\n* Group I : Resorbable device PLLA/PGA.\n* Group II : Titanium device.\n\nStudy visits :\n\n\\- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14.\n\nRandomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18\\<Age\\<50.\n* One or more fractures of facial massif requiring a surgical setting with osteosynthesis plates.\n* One or more osteotomy of facial massif requiring a surgical setting with osteosynthesis plates.\n* Orally and written informed patient. Patient willing to participate the study.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Any previous surgery at the same operative site.\n* Patient suffering from chronic affection which could interfere with bone consolidation.\n* Corticotherapy, immunosuppressive or anticonvulsant treatment or long term antibiotherapy.\n* Nursing or pregnant female.\n* Patient with a high risk of non compliance to sudy visits.\n* Unconscious patient.'}, 'identificationModule': {'nctId': 'NCT00240669', 'briefTitle': 'RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery - A Prospective Randomized Trial in Therapeutic Strategy', 'orgStudyIdInfo': {'id': '2004.366'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Resorbable device PLLA/PGA', 'type': 'DEVICE'}, {'name': 'Titanium device', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre BOULETREAU, MD', 'role': 'CONTACT', 'email': 'pierre.bouletreau@chu-lyon.fr', 'phone': '33 4 78 86 19 36'}], 'facility': 'Pierre Bouletreau', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Pierre BOULETREAU, MD', 'role': 'CONTACT', 'email': 'pierre.bouletreau@chu-lyon.fr', 'phone': '33 4 78 86 19 36'}], 'overallOfficials': [{'name': 'Pierre BOULETREAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civile de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}}}}