[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Orthopedic Hospital Vienna Speising\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Hallux Valgus",[27,29,30,31,32,33,34,35,36],"human allogeneic cortical bone screw","Shark Screw®","HVA","IMA","AOFAS","time to union","union rate","FFI","NOT_YET_RECRUITING","2026-03-29",{"date":40,"type":41},"2026-04-02","ACTUAL",{"date":43,"type":21},"2026-12-01",{"date":45,"type":21},"2028-12-31",{"name":47,"class":48},"Orthopedic Hospital Vienna Speising","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":49},"100488666","medial-displacement-calcaneal-osteotomy-and-fdl--transfer---with-a-human-allogeneic-cortical-bone-screw-100488666","NCT05643079","Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw","Medial Displacement Calcaneal Osteotomy and FDL- Transfer - a Prospective Comparative Study Between Metal\u002FBio-Tenodesis Screw (Arthrex) and the Human, Allogeneic Cortical Bone Screw (Shark Screw®️, Surgebright-GmbH)","Inclusion Criteria\n\n* Indication for the use of a metal\u002FBio-Tenodesis screw or human bone screw in medializing calcaneus osteotomy with FDL transfer.\n* BMI\\\u003C 40 kg\u002Fm²\n\nExclusion Criteria:\n\n* Insufficient knowledge of German\n* Alcohol and drug abuse\n* Pregnant woman or nursing mother\n* Foreseeable compliance problems\n* Neoplastic diseases, malignant bone tumors, rheumatoid arthritis\n* Active osteomyelitis\n* History of foot surgery\n* Advanced osteoarthritis of the lower ankle joint\n* Ulcerations in the skin of the surgical area\n* Immunosuppressive medications that cannot be discontinued\n* BMI \\>40",{"count":20,"type":21},"OBSERVATIONAL","The goal of this observational study is to compare the use of a screw made of human bone (Shark-Screw®, Surgebright-GmbH) with the metal\u002FBio-Tenodesis screw (Arthrex) in the treatment of the symptomatic flatfoot using the medializing calcaneus osteotomy with flexor digitorum longus transfer (FDL) in adult patients. The advantage of the human bone screw is that after surgery no hardware removal is necessary. The screw is transformed from the body to normal bone.\n\nThe main questions it aims to answer are:\n\n* Can the human bone screw achieve union rates like the metal\u002FBio-Tenodesis screw?\n* Is the time to union similar between the different screws?\n* Is the complication rate similar between the different screws?\n* Are the activity scores American Orthopaedic Foot and Ankle Society (AOFAS), Foot and Ankle Outcome Score (FAOS) and Foot Function Index (FFI) after surgery similar in the compared patient groups?\n\nParticipants will have\n\n* the surgery\n* follow-ups at 6 weeks, 6 months, 1 and 2 years.\n* X-rays are performed at each follow up.\n* CT-scans are performed after 6 months.\n* activity scores are collected at the follow up after 6 months, 1 year and 2 years.",[61,62,63,64],"Flat Feet","Flexor Tendon Rupture","Tibialis Posterior Dysfunction","Deformity, Foot",[29,30,66,67,68,69,70,71],"flat foot deformity","FDL Transfer","Tibialis posterior dysfunction","metal screw","Bio-Tenodesis screw","flat foot","RECRUITING","2025-03-17",{"date":75,"type":41},"2025-03-20",{"date":77,"type":41},"2022-02-10",{"date":79,"type":21},"2028-02",{"name":47,"class":48},""]