[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581951":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":51,"collaborators":31,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":31,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":31,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":31,"overallStatus":77,"whyStopped":31,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suture button fixation","EXPERIMENTAL","Patients undergoing suture button fixation of syndesmosis injury",[13],"Procedure: Suture button fixation",{"label":15,"type":10,"description":16,"interventionNames":17},"Syndesmotic screw fixation","Patients undergoing syndesmotic screw fixation of syndesmosis injury",[18],"Procedure: Syndesmotic screw fixation",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Patients undergoing suture button fixation of syndesmosis injury.",[9],[25],"Group A",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Patients undergoing syndesmotic screw fixation of syndesmosis injury.",[15],[30],"Group B",null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"El-Sayed S El-Gamasy, MBBCh","CONTACT","002 01206220396","elsayed.sherif@med.tanta.edu.eg",[39],{"facility":5,"status":31,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":31},"Tanta","El-Gharbia","31527","Egypt","EG",{"type":46,"coordinates":47},"Point",[48,49],31.00192,30.78847,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","El-Sayed Sherif Soliman El-Gamasy","Resident of Orthopedic Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.","100581951","syndesmotic-screw-vs-suture-button-in-ankle-syndesmotic-diastasis-100581951",false,"NCT06856980","Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis","Comparative Study Between Syndesmotic Screw and Suture Button in Ankle Syndesmotic Diastasis","Inclusion Criteria:\n\n\\- Unstable unilateral syndesmotic injuries that was considered by the attending staff surgeon to require surgical fixation, including:\n\n* Age : 18 - 60 years old.\n* Closed or grade I open fractures are included.\n* Isolated syndesmotic injury.\n* associated lateral malleolus fracture with talar shift.\n* Associated with Bimalleolar fractures.\n* Associated with Trimalleolar fractures that did not require posterior fragment fixation (typically \\\u003C25% of articular surface).\n\nExclusion Criteria:\n\n\\- Exclusion criteria include patient and injury specific factors.\n\nPatient-related exclusion factors included:\n\n* Skeletal immaturity.\n* Previous ipsilateral ankle surgery.\n* Non-ambulatory status before injury.\n* Inability to comply with postoperative protocol (i.e., advanced dementia).\n* Medical unfit patients for surgery.\n* Uncontrolled diabetes mellitus with charcot joint or peripheral neuropathy.\n* Polytrauma patients.\n\nInjury-related exclusion factors included:\n\n* Grade II or III open fractures\n* Tibial plafond fractures\n* Posterior malleolar fractures requiring fixation (typically \\>25% articular surface involved).","ALL","18 Years","60 Years",{"count":66,"type":67},42,"ESTIMATED","INTERVENTIONAL",[70],"NA","The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.",[73,74,75,76],"Syndesmotic Screw","Suture Button","Fixation","Ankle Syndesmotic Diastasis","NOT_YET_RECRUITING","2025-03-04",{"date":80,"type":81},"2025-03-06","ACTUAL",{"date":83,"type":67},"2025-03-15",{"date":85,"type":67},"2026-01-01",{"name":5,"class":6},1]