[{"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":31,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":31,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":31,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":31,"overallStatus":76,"whyStopped":31,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"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",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":65,"type":66},42,"ESTIMATED","INTERVENTIONAL",[69],"NA","The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.",[72,73,74,75],"Syndesmotic Screw","Suture Button","Fixation","Ankle Syndesmotic Diastasis","NOT_YET_RECRUITING","2025-03-04",{"date":79,"type":80},"2025-03-06","ACTUAL",{"date":82,"type":66},"2025-03-15",{"date":84,"type":66},"2026-01-01",{"name":5,"class":6},1]