[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614510":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":28,"locations":46,"responsibleParty":67,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":28,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":28,"enrollmentInfo":84,"targetDuration":28,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":104,"whyStopped":28,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Suez Canal University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Surgical Planning (VSP) - Prebent Miniplates","EXPERIMENTAL","Patients allocated to this arm will undergo preoperative CT segmentation and 3D reconstruction, virtual reduction of the zygomaticomaxillary complex, and 3D printing of the reduced model. Titanium miniplates will be prebent on the 3D printed model before surgery. Surgical fixation will then be performed under general anesthesia using the prebent titanium miniplates.",[13,14],"Procedure: Virtual surgical planning and 3D model printing","Device: Prebent titanium miniplates",{"label":16,"type":17,"description":18,"interventionNames":19},"Traditional Open Reduction and Fixation","ACTIVE_COMPARATOR","Patients allocated to this arm will undergo conventional open reduction and internal fixation of the ZMC fracture under general anesthesia without prior virtual surgical planning or 3D-printed models. Titanium miniplates will be contoured intraoperatively by the surgical team and used for fixation at the appropriate sites.",[20,21],"Procedure: Conventional open reduction and internal fixation (ORIF)","Device: Titanium miniplates and screws (Anton Hipp)",[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Virtual surgical planning and 3D model printing","Preoperative CT segmentation, virtual reduction of fracture fragments using 3D planning software, and printing of the reduced 3D anatomical model for plate prebending.",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DEVICE","Prebent titanium miniplates","Titanium miniplates prebent on the printed model and used for rigid internal fixation at standard zygomatic fixation points (frontozygomatic suture, infraorbital rim, zygomaticomaxillary buttress) as indicated.",[9],{"type":24,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Conventional open reduction and internal fixation (ORIF)","Standard surgical exposure and manual reduction of fracture fragments with intraoperative confirmation of alignment, followed by contouring and application of titanium miniplates and screws for fixation.",[16],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Titanium miniplates and screws (Anton Hipp)","Surgeon-contoured titanium miniplates applied intraoperatively at the necessary fixation points.",[16],[43],{"name":44,"affiliation":5,"role":45},"Hossam Shaban El Fadly, principle investigator","PRINCIPAL_INVESTIGATOR",[47],{"facility":5,"status":28,"city":48,"state":28,"zip":28,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Cairo","Egypt","EG",{"type":52,"coordinates":53},"Point",[54,55],31.24967,30.06263,{"lat":55,"lon":54},[58,62,65],{"name":28,"role":59,"phone":60,"phoneExt":28,"email":61},"CONTACT","+201127152090","hossax20@gmail.com",{"name":28,"role":59,"phone":63,"phoneExt":28,"email":64},"+201145007231","pgs.240089@dent.suez.edu.eg",{"name":66,"role":45,"phone":28,"phoneExt":28,"email":28},"Hossam Shaban El Fadly",{"type":45,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"hossam shaban","Principal Investigator, Department of Oral and Maxillofacial Surgery, Suez Canal University",[71],{"name":72,"class":73},"Suez canal university hospitals","UNKNOWN","100614510","accuracy-of-virtual-surgical-planning-versus-traditional-technique-in-zygomaticomaxillary-fracture-reduction-100614510",false,"NCT07280533","Accuracy of Virtual Surgical Planning Versus Traditional Technique in Zygomaticomaxillary Fracture Reduction","Accuracy of Virtual Surgical Planning in Reduction of Zygomatico-Maxillary Fractures A Randomized Clinical Controlled Study","Inclusion Criteria:\n\n* Adults (≥18 years) with clinically and radiographically confirmed ZMC fracture.\n* Fit for general anesthesia and able to undergo CT imaging.\n* Willing to sign informed consent.\n\nExclusion Criteria:\n\n* Systemic diseases impairing bone healing (osteoporosis, cancer, long-term steroid use).\n* Noncompliance or inability to attend follow-up visits.\n* ASA class IV-VI.\n* Previous facial deformities or fractures.",true,"ALL","18 Years",{"count":85,"type":86},20,"ESTIMATED","INTERVENTIONAL",[89],"NA","This randomized clinical trial aims to evaluate the accuracy and outcomes of virtual surgical planning (VSP) compared to the traditional surgical technique in the reduction of zygomaticomaxillary complex (ZMC) fractures. Twenty patients with ZMC fractures will be randomly assigned into two equal groups: one treated using virtual planning and prebent titanium miniplates, and the other treated conventionally without virtual planning. Clinical evaluation will include facial symmetry, eye movement, and postoperative complications, while radiographic assessment will be performed using CT scans three months after surgery to measure bone formation and alignment accuracy. The study seeks to determine whether virtual surgical planning improves anatomical restoration, esthetics, and functional outcomes compared to traditional methods.",[92,93,94],"Facial Bone Fracture","Maxillofacial Injury","Zygomaticomaxillary Complex Fracture",[96,97,98,99,31,100,101,102,103],"Zygomaticomaxillary complex fracture","ZMC fracture","Virtual surgical planning","3D printing","Facial symmetry","Computer-assisted surgery","CT evaluation","Traditional surgical method","NOT_YET_RECRUITING","2025-12-09",{"date":107,"type":108},"2025-12-12","ACTUAL",{"date":110,"type":86},"2025-12-25",{"date":112,"type":86},"2026-11-01",{"name":5,"class":6},1]