[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543532":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":76,"collaborators":26,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":26,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":26,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Bezirkskrankenhaus Schwaz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ACL reconstruction with human allogeneic cortical bone screw (Shark Screw®)","EXPERIMENTAL","The sugery techniqueis the same for both arms. An allograft screw (Shark Screw ACL®; Surgebright GmbH, A-4040 Lichtenberg, Austria) is used. At the beginning of the operation, the diagnosis is confirmed arthroscopically. The tendon is prepared. The bone tunnels will be created due to the size of the graft. The graft is pulled in and fixed with the intereference screw (Shark Screw ACL®). The tibial bone tunnel will be filled with cancellous chips. Finally, the graft is checked for strength and possible anterior or lateral pinching. The arthroscopic fluid is aspirated and the wound is closed.",[13],"Procedure: ACL reconstruction with Shark Screw ACL®",{"label":15,"type":16,"description":17,"interventionNames":18},"ACL reconstruction with Mecta Composite interference screw","ACTIVE_COMPARATOR","The sugery techniqueis the same for both arms. A Mecta-composite-screw, (Medacta, Castello San Pietro, Swiss) is used. At the beginning of the operation, the diagnosis is confirmed arthroscopically. The tendon is prepared. The bone tunnels will be created due to the size of the graft. The graft is pulled in and fixed with the intereference screw (Mecta-composite-screw, Medacta). The tibial bone tunnel will be filled with cancellous chips. Finally, the graft is checked for strength and possible anterior or lateral pinching. The arthroscopic fluid is aspirated and the wound is closed.",[19],"Procedure: ACL reconstruction with biocomposite screw (Mecta)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","ACL reconstruction with Shark Screw ACL®","ACL reconstruction with the Shark Screw ACL®, Investigation of tunnel widening",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"ACL reconstruction with biocomposite screw (Mecta)","ACL reconstruction with biocomposite screw (Mecta), Investigation of tunnel widening",[15],[32],{"name":33,"affiliation":34,"role":35},"Alexander Rofner-Moretti, MD","Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+435242600","alexander.rofner-moretti@kh-schwaz.at",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Markus Reichkendler, MD","markus.reichkendler@kh-schwaz.at",[45],{"facility":34,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Schwaz","Tyrol","6130","Austria","AT",{"type":53,"coordinates":54},"Point",[55,56],11.71014,47.35169,{"lat":56,"lon":55},[59,60,61,62,64,66,68,70,72,74],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":42,"role":63,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":65,"role":63,"phone":26,"phoneExt":26,"email":26},"Boris Tirala, MD",{"name":67,"role":63,"phone":26,"phoneExt":26,"email":26},"Martin Wallner, MD",{"name":69,"role":63,"phone":26,"phoneExt":26,"email":26},"Lukas Pöhl, MD",{"name":71,"role":63,"phone":26,"phoneExt":26,"email":26},"Samuel Dolling, MD",{"name":73,"role":63,"phone":26,"phoneExt":26,"email":26},"Edith Reches, MD",{"name":75,"role":63,"phone":26,"phoneExt":26,"email":26},"Clemens Lottersberger, MD",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Alexander Rofner-Moretti","Senior Physician Dr. med. Alexander Rofner-Moretti","100543532","acl-reconstruction-with-shark-screw-or-biocomposite-interference-screws-100543532",false,"NCT06357091","ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws","ACL Reconstruction With Human Allograft Cortical Bone Screw (Shark Screw®) or Biocomposite-interference Screws - a Prospective, Randomized, Controlled Trial.","Inclusion Criteria:\n\n* MRI-verified rupture of the anterior cruciate ligament\n* Indication for replacement surgery\n* Surgery within 6 months of injury\n* Uninjured contralateral knee\n\nExclusion Criteria:\n\n* Previous rupture of the anterior cruciate ligament on the side to be operated on (rerupture)\n* Primary bone disease\n* inflammatory disease\n* Unstable meniscus\n* complete rupture of a collateral ligament\n* early rerupture during the examination period (early rerupture)","ALL","18 Years",{"count":90,"type":91},80,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this clinical trial is to compare the outcome of 2 different screws for Anterior cruciate ligament reconstruction. The main question is if the human allogeneic cortical bone screw reduces tunnel widening in comparison to conventional treatment with a biocomposite screw. Additional the re-rupture rate will be evaluated and knee scores will be recorded before surgery and after surgery. Participants will have MRI before and after surgery, 3, 6, 12, and 24 months after surgery and Computertomography after surgery, 3, 6 and 24 months after surgery. Questionnaires (Knee-scores) will be recorded before surgery, 6, 12, 24 months after surgery.\n\nthe investigators hope that with the human cortical bone screw the tunnel widening is reduced and the re-rupture rate is low",[97,98,99],"Anterior Cruciate Ligament Rupture","Anterior Cruciate Ligament Reconstruction","Anterior Cruciate Ligament Injury",[101,102,103,104,105,106,107,108,109,110,111],"ACL","tunnel widening","human allogeneic cortical bone screw","Shark Screw®","biotenodese screw","re-rupture rate","IKDC","KOOS","Lysholm Knee Score","Tegner Activity Score","range of motion (ROM)","2026-01-17",{"date":114,"type":115},"2026-01-21","ACTUAL",{"date":117,"type":91},"2026-02-16",{"date":119,"type":91},"2034-01-31",{"name":78,"class":6},1]