[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650841":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":11,"locations":26,"responsibleParty":40,"collaborators":11,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":11,"eligibilityCriteria":47,"healthyVolunteers":44,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":11,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":11,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Institut Català de Traumatologia i Medicina de l'Esport","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A (TORN): tibial graft fixation bioabsorbable interference screw, same diameter as the tunnel.","ACTIVE_COMPARATOR",null,[13],"Procedure: Anterior cruciate ligament (ACL) reconstruction",{"label":15,"type":10,"description":11,"interventionNames":16},"Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"PROCEDURE","Anterior cruciate ligament (ACL) reconstruction","The three different types of tibial fixation in ACL reconstruction with Hamstring autograft:\n\nGroup A (TORN): bioabsorbable interference screw, same diameter as the tunnel.\n\nGroup B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.\n\nGroup C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button\u002Fplate.",[9,15,18],[27],{"facility":28,"status":11,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":11},"Hospital Universitario Dexeus","Barcelona","BARCELONA","08028","Spain","ES",{"type":35,"coordinates":36},"Point",[37,38],2.15899,41.38879,{"lat":38,"lon":37},{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100650841","influence-of-the-different-types-of-tibial-fixation-in-the-reconstruction-of-the-anterior-cruciate-ligament-of-the-knee-osseous-integration-ligament-maturation-and-clinical-results-100650841",false,"NCT07753707","Influence of the Different Types of Tibial Fixation in the Reconstruction of the Anterior Cruciate Ligament of the Knee: Osseous Integration, Ligament Maturation and Clinical Results.","Inclusion Criteria\n\nAge ≥18 years.\n\nComplete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.\n\nExclusion Criteria\n\nAge ≥55 years.\n\nPatients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts.\n\nMalpositioned tunnels (evaluated by MRI at 6 months postop).\n\nPrevious knee surgery.\n\nFemoral or tibial deformities.\n\nMultiligament injuries.\n\nNote: Soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.","ALL","18 Years","55 Years",{"count":52,"type":53},111,"ESTIMATED","INTERVENTIONAL",[56],"NA","Influence of different tibial fixation methods in anterior cruciate ligament (ACL) reconstruction: bone integration, graft maturation, and clinical outcomes.\n\nPrimary Objective\n\nTo assess whether any of the four tibial fixation techniques is superior in terms of:\n\nGraft-bone integration (CT\u002FMRI),\n\nGraft maturation (MRI),\n\nClinical outcomes (IKDC, Lysholm, Tegner scores; manual and instrumented knee stability with KT-1000 arthrometer).\n\nSecondary Objectives\n\nCompare clinical outcomes among groups (IKDC, Lysholm, Tegner).\n\nCompare re-rupture rates and patient satisfaction.\n\nStudy Design\n\nProspective randomized trial.\n\nThe study will be registered in the international Clinical Trials registry.\n\nInclusion Criteria\n\nAge ≥18 years.\n\nComplete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.\n\nExclusion Criteria\n\nAge ≥55 years.\n\nPatients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts.\n\nMalpositioned tunnels (evaluated by MRI at 6 months postop).\n\nPrevious knee surgery.\n\nFemoral or tibial deformities.\n\nMultiligament injuries.\n\nNote: Soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.\n\nRandomization\n\nPatients meeting inclusion\u002Fexclusion criteria will be randomized (via Research Randomizer: https:\u002F\u002Fwww.randomizer.org\u002F\n\n) into 3 groups:\n\nGroup A (TORN): bioabsorbable interference screw, same diameter as the tunnel.\n\nGroup B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.\n\nGroup C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button\u002Fplate.\n\nSample size: 37 patients per group, 111 total.\n\nFollow-up\n\nRadiographic, CT, and MRI evaluation pre-op, at 15 days, and at 1 year post-op.\n\nClinical and radiological follow-up for 1 year.\n\nStatistical Analysis\n\nIn the prospective phase, Student's t-test will be performed for comparison of pre- and postoperative variables. All variables will also be compared between groups and within groups (baseline vs. end of follow-up) using analysis of variance (ANOVA).\n\nLinear regression models will be applied to test for potential significance that could be masked by confounding factors.",[59],"ACL - Anterior Cruciate Ligament Rupture","ACTIVE_NOT_RECRUITING","2026-08-04",{"date":63,"type":64},"2026-08-07","ACTUAL",{"date":66,"type":64},"2023-01-07",{"date":68,"type":53},"2026-12-30",{"name":5,"class":6},1]