protocolSection identificationModule nctId: NCT06357091, orgStudyIdInfo id: 1097/2023 ACL-Shark Screw®, briefTitle: ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2031-06-01, completionDateStruct date: 2031-06-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Bezirkskrankenhaus Schwaz, class: OTHER, descriptionModule briefSummary: 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.the investigators hope that with the human cortical bone screw the tunnel widening is reduced and the re-rupture rate is low, conditionsModule conditions: Anterior Cruciate Ligament Rupture, conditions: Anterior Cruciate Ligament Reconstruction, conditions: Anterior Cruciate Ligament Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: ACL reconstruction with Shark Screw ACL®, interventions name: ACL reconstruction with biocomposite screw (Mecta), outcomesModule primaryOutcomes measure: bone tunnel widening will be measured by CT and/or MRI and measured in mm, secondaryOutcomes measure: International Knee Documentation Committee (IKDC) Scores, secondaryOutcomes measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores, secondaryOutcomes measure: Lysholm Knee Score, secondaryOutcomes measure: Tegner Activity Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H., city: Schwaz, state: Tirol, zip: 6130, country: Austria, contacts name: Alexander Rofner-Moretti, MD, role: CONTACT, phone: +435242, phoneExt: 600, email: alexander.rofner-moretti@kh-schwaz.at, contacts name: Markus Reichkendler, MD, role: CONTACT, phone: +435242, phoneExt: 600, email: markus.reichkendler@kh-schwaz.at, geoPoint lat: 47.35169, lon: 11.71014, locations facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H, city: Schwaz, state: Tirol, zip: 6130, country: Austria, contacts name: Alexander Rofner-Moretti, MD, role: CONTACT, phone: +435242600, email: alexander.rofner-moretti@kh-schwaz.at, contacts name: Markus Reichkendler, MD, role: CONTACT, phone: +435242600, email: markus.reichkendler@kh-schwaz.at, contacts name: Alexander Rofner-Moretti, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Markus Reichkendler, MD, role: SUB_INVESTIGATOR, contacts name: Boris Tirala, MD, role: SUB_INVESTIGATOR, contacts name: Martin Wallner, MD, role: SUB_INVESTIGATOR, contacts name: Lukas Pöhl, MD, role: SUB_INVESTIGATOR, contacts name: Samuel Dolling, MD, role: SUB_INVESTIGATOR, contacts name: Edith Reches, MD, role: SUB_INVESTIGATOR, contacts name: Clemens Lottersberger, MD, role: SUB_INVESTIGATOR, geoPoint lat: 47.35169, lon: 11.71014, hasResults: False