[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536236":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":60,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":91,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Orthopedic Hospital Vienna Speising","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"conventional group","standard surgery with metal screw",[12],"Procedure: Hallux Valgus Treatment with metal screw",{"label":14,"type":15,"description":16,"interventionNames":17},"Shark Screw® group","EXPERIMENTAL","new surgical procedure with human allogeneic cortical bone screw",[18],"Procedure: Hallux Valgus Treatment with Shark Screw®",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Hallux Valgus Treatment with Shark Screw®","This is a prospective, randomised study in which hallux valgus is corrected by means of a chevron\u002Fkin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \\& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS\u002FFFI.",[14],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Hallux Valgus Treatment with metal screw",[9],[30],{"name":31,"affiliation":32,"role":33},"Florian Wenzel-Schwarz, MD","Orthopädisches Spital Speising","PRINCIPAL_INVESTIGATOR",[35,40],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","+43180182","3081","florian.wenzel@oss.at",{"name":41,"role":36,"phone":25,"phoneExt":25,"email":42},"Andreas Kranzl, PhD","Andreas.Kranzl@oss.at",[44],{"facility":45,"status":25,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising","Vienna","1130","Austria","AT",{"type":51,"coordinates":52},"Point",[53,54],16.37208,48.20849,{"lat":54,"lon":53},[57,59],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":58},"florian.wenzel-schwarz@oss.at",{"name":31,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Forian Wenzel-Schwarz","principal investigator","100536236","hallux-valgus-correction-using-the-metal-screw-or-the-human-allogeneic-cortical-bone-screw-shark-screw-100536236",false,"NCT06262204","Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw).","Clinical and Radiological Comparison of Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw, a Prospective Study","Inclusion Criteria:\n\n* between 18 and 85\n* confirmed Hallux Valgus\n\nExclusion Criteria:\n\n* \\\u003C18 years and \\>85 years\n* Known underlying oncological disease\n* Pregnant women or breastfeeding mothers\n* Alcohol and drug abuse\n* Foreseeable compliance problems\n* Foreseeable loss of responsibility as a study doctor\n* Neoplastic diseases\n* Active osteomyelitis\n* Ulcerations in the area of the skin of the surgical site\n* Immunosuppressive medication that cannot be discontinued","ALL","18 Years","85 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.\n\nThe main questions it aims to answer are:\n\nCan the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized.",[81],"Hallux Valgus",[81,83,84,85,86,87,88,89,90],"human allogeneic cortical bone screw","Shark Screw®","HVA","IMA","AOFAS","time to union","union rate","FFI","NOT_YET_RECRUITING","2026-03-29",{"date":94,"type":95},"2026-04-02","ACTUAL",{"date":97,"type":75},"2026-12-01",{"date":99,"type":75},"2028-12-31",{"name":5,"class":6},1]