[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558666":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":27,"locations":28,"responsibleParty":50,"collaborators":27,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":27,"enrollmentInfo":63,"targetDuration":27,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":77,"overallStatus":81,"whyStopped":27,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Deep Health Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Medical Device- PathKeeper System (PKS)","EXPERIMENTAL","One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.\n\nIntervention: Medical Device - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.",[13],"Device: Medical Device - PKS",{"label":15,"type":16,"description":17,"interventionNames":18},"2D Fluoroscopy","ACTIVE_COMPARATOR","Control arm: Standard of care - free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Medical Device - PKS","The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.",[15,9],[26],"Device- Fluoroscopy",null,[29],{"facility":30,"status":27,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Leeds Hospital","Leeds","West Yorkshire","LS9 7TF","United Kingdom","UK",{"type":37,"coordinates":38},"Point",[39,40],-1.54785,53.79648,{"lat":40,"lon":39},[43,48],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},"Almas Khan, MD","CONTACT","+44 113 392 8575","almas.khan@nhs.net",{"name":44,"role":49,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100558666","study-comparing-the-pathkeeper-system-for-pedicle-screw-positioning-in-spine-surgery-with-traditional-care-100558666",false,"NCT06554093","Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care","A Prospective, Dual Canter, Double Armed, Open Label, Clinical Study to Evaluate the Performance of the PathKeeper System for Pedicle Screw Positioning in Spine Surgery","PKSforPSP","Inclusion Criteria:\n\n* Men and women\n* 16 and above years old\n* Patients who are about to undergo open, instrumented spinal surgery\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Men and women\n* 16 and above years old\n* Patients who are about to undergo open, instrumented spinal surgery\n* Signed informed consent form",true,"ALL","16 Years",{"count":64,"type":65},32,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question\\[s\\]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS) with control arm",[71,72,73,74,75,76],"Scoliosis","Scoliosis; Adolescence","Scoliosis Kyphosis","Scoliosis Lumbar Region","Scoliosis Thoracic Region","Pathologic Fracture",[78,79,80],"fusion","screw positioning","screw insertion","NOT_YET_RECRUITING","2025-02-03",{"date":84,"type":85},"2025-02-05","ACTUAL",{"date":87,"type":65},"2025-10-30",{"date":87,"type":65},{"name":5,"class":6},1]