[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427860":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":45,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Fraser Orthopaedic Research Society","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dynamic rotational locking","ACTIVE_COMPARATOR","Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance less than 25mm. The compression nut will be used to compress the fracture. The screw will be rotationally locked by using the 5mm hex flexible screwdriver by advancing the set screw until it stops completely. The screw will then be turned counterclockwise by a ½ turn.",[13],"Procedure: Dynamic Rotational Locking",{"label":15,"type":16,"description":17,"interventionNames":18},"Static locking","EXPERIMENTAL","Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance of less than 25mm. The compression nut will be used to compress the fracture. The screw will then be statically locked using the 6Nm torque-limiting blue handle with 6mm hex coupling to completely lock the set screw down on the helical screw.",[19],"Procedure: Static Locking",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Dynamic Rotational Locking","Performed, as per the Synthes technique guide, using the 5mm hex flexible set screwdriver and then loosening the set screw by one-half turn of the screwdriver.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Static Locking","Performed by using the torque-limiting set screwdriver and locking the set screw down onto the helical screw to prevent dynamic sliding of the screw within the nail.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Bertrand Perey, MD, FRCSC","Royal Columbian Hospital\u002FFraser Health Authority","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"David Cinats, MD","Orthopaedic Surgeon, Fraser Health Authority",[40],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Kyrsten Butterfield, BSc","CONTACT","604-553-3247","kyrsten.butterfield@fraserhealth.ca",[46],{"facility":34,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","New Westminster","British Columbia","V3L 3W7","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-122.91092,49.20678,{"lat":57,"lon":56},[60],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[64],{"name":65,"class":66},"DePuy Synthes","INDUSTRY","100427860","static-helical-screw-locking-of-pertrochanteric-femur-fractures-using-the-tfn-a-100427860",false,"NCT04851509","Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A","Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-Advanced Proximal Femoral Nailing System - a Randomized Trial","TFN-A","Inclusion Criteria:\n\n* Patients \\>18 years of age\n* AO\u002FOTA 31-A fractures who the surgeon deems eligible for treatment with a cephalomedullary nail\n* Open and closed fractures\n* Ambulatory prior to injury (with or without walking aides)\n* Native (non-fractured, no implant) contralateral hip\n* Willing and able to sign consent (substitute decision maker)\n\nExclusion Criteria:\n\n* Contralateral hip fracture or hip arthroplasty\n* Fracture not amenable to treatment with a cephalomedullary nail\n* Non-ambulatory patient\n* Fractures \\>14 days (time of injury to OR)\n* Bilateral pertrochanteric hip fractures\n* Non-unions\n* Pathologic fractures\n* Periprosthetic fractures\n* Patients with spinal injury\n* Incarceration\n* Pregnancy\n* Limited life expectancy due to significant medical co-morbidities or medical contra-indications to surgery\n* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).","ALL","18 Years",{"count":78,"type":79},218,"ESTIMATED","INTERVENTIONAL",[82],"NA","The study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. This is a randomized control study with the initial invention being randomized to either statically locking or dynamically locking. For a two-month period, all eligible patients will receive the randomized allocated treatment, then treatment will switch to the alternate treatment for the next two months and will continue to alternate treatments for two-month periods until study enrollment has completed.",[85],"Pertrochanteric Fracture","2025-02-26",{"date":88,"type":89},"2025-02-28","ACTUAL",{"date":91,"type":89},"2021-05-17",{"date":93,"type":79},"2027-01",{"name":5,"class":6},1]