[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488666":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Orthopedic Hospital Vienna Speising","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"metal\u002FBio-Tenodesis group",null,"medializing calcaneal osteotomy, debridement of the tibialis posterior tendon, and\u002For transfer of the flexor digitorum longus (FDL) tendon with the following screws:\n\nMetal-\u002FBio-Tenodesis screw (Arthrex, Naples, Florida, USA)\n\nMetal-Screw:\n\nø 6,7 mm length: 40-60 mm\n\nBio-Tenodesis screw:\n\nø 4,00 mm, length: 10 mm ø 4,75 mm, length: 15 mm ø 5,50 mm, length: 15 mm",[13],"Procedure: medializing calcaneal osteotomy and\u002For transfer of the flexor digitorum longus tendon (FDL) with metal\u002FBio-Tenodesis screws",{"label":15,"type":10,"description":16,"interventionNames":17},"human, allogeneic cortical bone screw (Shark Screw®)","medializing calcaneal osteotomy, debridement of the tibialis posterior tendon, and\u002For transfer of the flexor digitorum longus (FDL) tendon with the following screws:\n\nShark Screw® (Surgebright-GmbH, 4040 Lichtenberg, Austria)\n\nVersions used:\n\nShark Screw® diver ø: 5,0 mm, length: 35 mm Shark Screw® diver ø: 5,0 mm, length: 45 mm Shark Screw® tendon ø: 5,0 mm, length: 15 mm",[18],"Procedure: medializing calcaneal osteotomy and\u002For transfer of the flexor digitorum longus tendon (FDL) with Shark Screws®",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","medializing calcaneal osteotomy and\u002For transfer of the flexor digitorum longus tendon (FDL) with metal\u002FBio-Tenodesis screws","The calcaneus osteotomy is performed dorsal proximal to plantar distal with caution of the peroneal tendons and sural nerve. After mobilization the dorsal fragment is displaced medially by\\~10mm. Thereafter, a guide wire is placed from plantar-lateral into the ventral portion of the calcaneus under fluoroscopic control. After stab incision and length measurement, the osteotomy is fixed with a Metal\u002FBio-Tenodesis screw(MBS). The lateral projection of the edge is straightened. Opening of the tendon sheath of the FDL muscle and dissection distally to Henry's node. Settling of the tendon and arming with a \"shuttle suture\". Tendon diameter measurement. Place a guide wire at os naviculare directed from plantar to dorsal in 20°proximal guidance. Pull through the FDL tendon from plantar to dorsal and fixation with an MBS in 20°of pointed foot position and inversion with appropriate desired tension. The tendon is then sutured to the stump of the tibialis posterior tendon, retinaculum sutures.",[9],[26],"Metal\u002FBio-Tenodesis screw intervention",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"medializing calcaneal osteotomy and\u002For transfer of the flexor digitorum longus tendon (FDL) with Shark Screws®","The calcaneus osteotomy is performed dorsal proximal to plantar distal with caution of the peroneal tendons and sural nerve. After mobilization the dorsal fragment is displaced medially by approx.10mm. Thereafter, a guide wire is placed from plantar-lateral into the ventral portion of the calcaneus under fluoroscopic control. After stab incision and length measurement, the osteotomy is fixed with a Shark Screw®. The lateral projection of the edge is straightened. Opening of the tendon sheath of the FDL muscle and dissection distally to Henry's node. Settling of the tendon and arming with a \"shuttle suture\". Tendon diameter measurement. Place a guide wire at os naviculare directed from plantar to dorsal in 20°proximal guidance. Pull through the FDL tendon from plantar to dorsal and fixation with the Shark Screw® in 20°of pointed foot position and inversion with appropriate desired tension. The tendon is then sutured to the stump of the tibialis posterior tendon, retinaculum sutures.",[15],[32],"Shark Screw® intervention",[34],{"name":35,"affiliation":36,"role":37},"Florian Wenzel-Schwarz, MD","Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising, Vienna, Austria","PRINCIPAL_INVESTIGATOR",[39],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+43180182","3081","florian.wenzel-schwarz@oss.at",[45],{"facility":46,"status":47,"city":48,"state":10,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising","RECRUITING","Vienna","1130","Austria","AT",{"type":53,"coordinates":54},"Point",[55,56],16.37208,48.20849,{"lat":56,"lon":55},[59,60],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":35,"role":37,"phone":10,"phoneExt":10,"email":10},{"type":37,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Forian Wenzel-Schwarz","Senior Physician Dr. med.","100488666","medial-displacement-calcaneal-osteotomy-and-fdl--transfer---with-a-human-allogeneic-cortical-bone-screw-100488666",false,"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","ALL","18 Years",{"count":74,"type":75},40,"ESTIMATED","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.",[79,80,81,82],"Flat Feet","Flexor Tendon Rupture","Tibialis Posterior Dysfunction","Deformity, Foot",[84,85,86,87,88,89,90,91],"human allogeneic cortical bone screw","Shark Screw®","flat foot deformity","FDL Transfer","Tibialis posterior dysfunction","metal screw","Bio-Tenodesis screw","flat foot","2025-03-17",{"date":94,"type":95},"2025-03-20","ACTUAL",{"date":97,"type":95},"2022-02-10",{"date":99,"type":75},"2028-02",{"name":5,"class":6},1]