[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472224":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":41,"responsibleParty":60,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":25,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Free-Hand Surgery (FHS)","ACTIVE_COMPARATOR","In FHS, the site surgeon will proceed with the surgery as per their routine practice.",[13],"Procedure: Free-Hand Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Virtual Surgical Planning (VSP)","EXPERIMENTAL","The trial research engineer (RE), located at Vancouver General Hospital (VGH), will segment the CT data to create a 3D model for surgical planning. During the teleconference between site surgeon (SS) and RE, the RE will load the CT data and the segmented 3D model into the virtual planning environment. With the RE navigating the software, which was created in-house at VGH and used in a previous case series, the SS will determine the extent of disease and define the resection planes. After the cutting planes are created, the RE will use the software to create the reconstruction plan with either the patient-specific fibula or scapula. Once the surgeon is satisfied with the plan, the teleconference will end and the RE will create and 3D print the surgical guides for the mandible, for the fibula or scapula, as well as the 3D computed reconstruction.",[19],"Procedure: Virtual Surgical Planning (VSP)",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","The 3D reconstruction model, not requiring sterilization, will be sent directly to the SS. Prior to surgery, the SS will prebend a titanium fixation plate to the reconstruction model. Both the surgical cutting guides and titanium plate will be sterilized prior to use in surgery. If the planned resection cannot proceed (possibly due to tumour growth), the surgical team will note the reason for abandonment and conduct a standard FHS. Intraoperatively, the SS will apply the mandibular cutting guide to make the resection, remove the resected component and apply the pre-bent plate. Next, either the fibular or scapular cutting guide is applied to harvest the transplant which is then secured to the plate. The flap is re-vascularized by joining it to blood vessels in the neck.",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Free-Hand Surgery","The SS will adopt their standard procedure for the mandibular resection and reconstruction. This typically involves bending a titanium fixation plate, harvesting of the bony flap, and shaping of the segments all intraoperatively based on the SS's judgement.",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Eitan Prisman, MD, FRCSC","CONTACT","6048754126","eitan.prisman@ubc.ca",{"name":37,"role":33,"phone":38,"phoneExt":39,"email":40},"Tayo Steininger","6048754111","22935","tstein12@student.ubc.ca",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Vancouver General Hospital","RECRUITING","Vancouver","British Columbia","V5Z1M9","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-123.11934,49.24966,{"lat":54,"lon":53},[57,59],{"name":58,"role":33,"phone":34,"phoneExt":25,"email":35},"Eitan Prisman, MD MA FRCSC",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":40},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Eitan Prisman","Clinical Associate Professor","100472224","mandibular-reconstruction-preplanning-vipmr-100472224",false,"NCT05429099","Mandibular Reconstruction Preplanning (ViPMR)","Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial","ViPMR","Inclusion Criteria:\n\n* primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery\n* are over the age of 18\n* cognitive ability and language skills that allow participation in the trial\n* provide informed consent\n\nExclusion Criteria:\n\n* severe comorbidities including metastatic disease\n* do not have a recent (within 30 days) CT scan and are unable\u002Funwilling to receive a head CT scan at the latest 6 days prior to surgery\n* prior history of head or neck cancer within last 5 years\n* prior history of head or neck radiation treatment at any time\n* pregnant of lactating women","ALL","18 Years",{"count":75,"type":76},420,"ESTIMATED","INTERVENTIONAL",[79],"NA","Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.",[82,83],"Oral Cavity Cancer","Oral Cancer",[82,83,85],"Mandibular Reconstruction","2026-05-28",{"date":88,"type":89},"2026-06-01","ACTUAL",{"date":91,"type":89},"2022-10-15",{"date":93,"type":76},"2028-10-15",{"name":5,"class":6},1]