Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-26 @ 10:35 AM
Study NCT ID:
NCT01121159
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2010-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2010-05-07', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shape and volume assessing software', 'timeFrame': 'up to 3 days after surgery', 'description': 'A post-op CT or CBCT scan will be analyzed with specially developed software that can compare shape and volume of the reconstruced orbit to the uninjured orbit.'}], 'secondaryOutcomes': [{'measure': 'shape and volume assessing software', 'timeFrame': 'up to 3 days after surgery', 'description': '6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit'}, {'measure': 'Clinical tests to assess vision', 'timeFrame': 'up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery', 'description': 'Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests'}, {'measure': 'Rate of complications', 'timeFrame': 'up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery', 'description': 'Complications will be documented at every follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Orbital Floor Fracture', 'Medial Orbital Wall Fracture']}, 'referencesModule': {'references': [{'pmid': '27519662', 'type': 'RESULT', 'citation': 'Zimmerer RM, Ellis E 3rd, Aniceto GS, Schramm A, Wagner ME, Grant MP, Cornelius CP, Strong EB, Rana M, Chye LT, Calle AR, Wilde F, Perez D, Tavassol F, Bittermann G, Mahoney NR, Alamillos MR, Basic J, Dittmann J, Rasse M, Gellrich NC. A prospective multicenter study to compare the precision of posttraumatic internal orbital reconstruction with standard preformed and individualized orbital implants. J Craniomaxillofac Surg. 2016 Sep;44(9):1485-97. doi: 10.1016/j.jcms.2016.07.014. Epub 2016 Jul 21.'}, {'pmid': '29530645', 'type': 'RESULT', 'citation': 'Zimmerer RM, Gellrich NC, von Bulow S, Strong EB, Ellis E 3rd, Wagner MEH, Sanchez Aniceto G, Schramm A, Grant MP, Thiam Chye L, Rivero Calle A, Wilde F, Perez D, Bittermann G, Mahoney NR, Redondo Alamillos M, Basic J, Metzger M, Rasse M, Dittman J, Rometsch E, Espinoza K, Hesse R, Cornelius CP. Is there more to the clinical outcome in posttraumatic reconstruction of the inferior and medial orbital walls than accuracy of implant placement and implant surface contouring? A prospective multicenter study to identify predictors of clinical outcome. J Craniomaxillofac Surg. 2018 Apr;46(4):578-587. doi: 10.1016/j.jcms.2018.01.007. Epub 2018 Feb 1.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/27519662', 'label': 'Link to published results'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/29530645', 'label': 'Link to published results'}]}, 'descriptionModule': {'briefSummary': 'Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with fractures of the orbital floor and/or medial orbital wall in one of the study centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≥ 18 years\n2. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor\n3. Scheduled for reconstruction surgery with one of the following implants:\n\n * MatrixMIDFACE Preformed Orbital Plate\n * Custom-made orbital implant\n * Orbital Floor Mesh Plate\n * SynPOR Titanium Reinforced Fan Sheet\n4. At least partial sight in both eyes before the accident\n5. Willingness and ability to participate in the study follow-up according to the protocol\n6. Ability to understand and read local language at elementary level\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. Bilateral orbital fracture\n2. Fractures of the orbital roof\n3. Comminuted zygoma fracture\n4. More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure\n5. Previous dislocated orbital fractures on either side\n6. Vision or diplopia not assessable\n7. Injury of the globe\n8. Neurological diseases with influence on eye motility or sight\n9. Legal incompetence\n10. Active malignancy\n11. Life-threatening condition\n12. Alcohol and drug abuse'}, 'identificationModule': {'nctId': 'NCT01121159', 'acronym': 'Orbita 3', 'briefTitle': 'Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'A Prospective Multicenter Study to Compare the Accuracy of Posttraumatic Orbital Reconstruction of the Medial Orbital Wall and/or the Orbital Floor With Preoperatively Preformed Versus Non-preformed Orbital Plates', 'orgStudyIdInfo': {'id': 'Orbita3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preoperatively preformed orbital plates', 'description': 'Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant', 'interventionNames': ['Procedure: orbital fracture repair']}, {'label': 'Non-preformed orbital plates', 'description': 'Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes)', 'interventionNames': ['Procedure: orbital fracture repair']}], 'interventions': [{'name': 'orbital fracture repair', 'type': 'PROCEDURE', 'description': 'All patients will receive orbital fracture repair with one of the 4 specified implants', 'armGroupLabels': ['Non-preformed orbital plates', 'Preoperatively preformed orbital plates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229-3900', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Bundeswehrkrankenhaus Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de 12 Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Niels Gellrich, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Hachschule Hannover'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Clinical Investigation and Publishing Documentation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}