[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517659":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":42,"locations":51,"responsibleParty":74,"collaborators":26,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":26,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Federal University of Piaui","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"O-Arm neuronavigator","ACTIVE_COMPARATOR","The O-ARM imaging system can help surgeons to view the spine in real time and verify the placement of implants such as screws or rods. Primarily, therefore, in image acquisition, during surgery, the O-ARM is activated and generates real-time images of the patient's spine, so that these images are displayed on a screen, allowing the surgeon to visualize the anatomical structures and check that implant placement is proper. Therefore, when analyzing these images, the surgeon can, for example, analyze and verify the placement of the implants and ensure that the arthrodesis is performed correctly, in such a way that, if necessary, the surgeon can make adjustments and then acquire new images for verification.",[13],"Device: O-ARM (Medtronic, Inc, Louisville, CO)",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional","PLACEBO_COMPARATOR","The conventional procedure for spinal arthrodesis will involve the intervertebral disc removal step between the vertebrae that will be fused. This is done precisely to create space for the bone graft that will be placed later. Then, there is bone surface preparation, where you prepare the bone surfaces of the vertebrae that will be fused, removing any soft tissue that might interfere with bone fusion. Then, there is bone graft placement, where the surgeon places a bone graft between the vertebrae that will be fused together. This graft can be obtained from another part of the patient's body (such as the pelvis) or from a deceased donor. Then, in the spinal column fixation step, rods, screws and\u002For plates are used to fix the vertebrae that will be fused.",[19],"Procedure: Conventional corrective surgery for arthrodesis",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","O-ARM (Medtronic, Inc, Louisville, CO)","scanner that allows imaging of screws intraoperatively",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Conventional corrective surgery for arthrodesis","Conventional procedure without neuronavigation guide",[15],[33,36,39],{"name":34,"affiliation":5,"role":35},"Carlos Eduardo B Lima, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":5,"role":38},"Denilson G Italiano, Sr.","STUDY_CHAIR",{"name":40,"affiliation":41,"role":38},"Mauricio Giraldi, MD, MSc","University Hospital of Federal University of Piaui",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},"Carlos E Lima, MD, PhD","CONTACT","+5586981805000","carlos.lima@ufpi.edu.br",{"name":37,"role":45,"phone":49,"phoneExt":26,"email":50},"+5586994804115","denilsonitaliano@ufpi.edu.br",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Carlos Eduardo Batista de Lima","RECRUITING","Teresina","Piauí","64048-350","Brazil","BR",{"type":61,"coordinates":62},"Point",[63,64],-42.80194,-5.08917,{"lat":64,"lon":63},[67,70],{"name":68,"role":45,"phone":69,"phoneExt":26,"email":47},"Carlos Eduardo B de Lima, MD, PhD","86981805000",{"name":71,"role":45,"phone":72,"phoneExt":26,"email":73},"Amanda Sousa","86994615203","admin@cardiolima.com.br",{"type":35,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Carlos Eduardo Batista de Lima, MD, PhD","Associate Professor, MD, PhD","100517659","pedicle-screw-malposition-in-spine-arthrodesis-surgeries-with-o-arm-guided-navigation-100517659",false,"NCT06020417","Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation","Occurrence of Pedicle Screw Malposition in Spine Arthrodesis Surgeries Performed With O-ARM-guided Navigation at a University Hospital: a Randomized Controlled Trial","NoHARM","Inclusion Criteria:\n\n* spine deformities (spinal cord trauma, osteoarthritis, intervertebral disc degeneration, degenerative or isthmic spondylolisthesis, intervertebral disc degeneration, spinal stenosis and degenerative scoliosis).\n\nExclusion Criteria:\n\n* anatomical abnormalities that can not be used the neuronavigation.","ALL","18 Years",{"count":88,"type":89},124,"ESTIMATED","INTERVENTIONAL",[92],"NA","Background: Throughout the history of spinal deformity there have been continuous advances in the surgical treatment. Although many techniques have been successfully developed despite the anatomy complex, screw placement still remains difficult with a significant risk of misplaced implants. The O-ARM guided Navigation is a scanner that allows imaging of screws intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence of misplaced implants. Methods: This is a prospective and randomized clinical study that will be carried out at the University Hospital of the Federal University of Piaui, which provides exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.",[95,96,97],"Spinal Fusion","Spinal Deformity","Spine Injury",[99,100,101],"neuronavigation","spinal deformity","Spine injury","2024-09-24",{"date":104,"type":105},"2024-09-25","ACTUAL",{"date":107,"type":105},"2024-08-01",{"date":109,"type":89},"2025-12-31",{"name":5,"class":6},1]