[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512484":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":46,"responsibleParty":63,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Schulthess Klinik","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ACLr with bone\u002FPrP-composite","EXPERIMENTAL","During surgery, the drilled bone debris is collected in a sterile filtered chamber.\n\nThen the bone debris is mixed with PrP. After fixation of the graft the composite is inserted into the drilled tunnel at the interface between tendon to bone. The intraarticular aperture sites are sealed by use of fibrin that is previously gathered out of the PrP as well.",[13],"Procedure: ACL reconstruction with bone\u002FPrP-composite",{"label":15,"type":16,"description":17,"interventionNames":18},"ACLr standard","ACTIVE_COMPARATOR","No insertion of additional material after ACL graft fixation.",[19],"Procedure: ACL reconstruction (Standard)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","ACL reconstruction with bone\u002FPrP-composite","During standard ACL reconstruction, the drilled bone debris is collected in a sterile filtered chamber.\n\nThen the bone debris is mixed with PrP. After fixation of the graft the composite is inserted into the drilled tunnel at the interface between tendon to bone. The intraarticular aperture sites are sealed by use of fibrin that is previously gathered out of the PrP as well.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"ACL reconstruction (Standard)","Standard ACL reconstruction with Semitendinosus alone or plus gracilis, femoral fixation via extracortical fixation by adjustable loop device, tibial fixation via a bio-interference screw or adjustable device",[15],[32],{"name":33,"affiliation":5,"role":34},"Gian Salzmann, Prof.","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Vincent A Stadelmann, PhD","CONTACT","+41 44 385","75 87","vincent.stadelmann@kws.ch",{"name":43,"role":38,"phone":39,"phoneExt":44,"email":45},"Anika Stephan, MA","79 84","anika.stephan@kws.ch",[47],{"facility":5,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Zurich","8008","Switzerland","CH",{"type":54,"coordinates":55},"Point",[56,57],8.55,47.36667,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":26,"email":45},"Anika Stephan","+41443857984",{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100512484","tunnel-widening-in-augmented-acl-integration-via-prp-enriched-collected-autologous-bone-vs-standard-acl-technique-100512484",false,"NCT05953051","Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique","A Single-center, Patient-blinded, Randomized, 2-year, Parallel-group, Superiority Study to Compare the Efficacy of Augmented ACL Integration Via Platelet-rich-plasma Enriched Collected Autologous Bone Versus Standard ACL Technique","Inclusion Criteria:\n\n* Age 18-50 years\n* Primary ACL rupture\n* Time from injury to surgery: 4 weeks to 6 months\n* Single ACL rupture (isolated rupture)\n* ACL surgery with one of the participating senior surgeons\n* Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* Concomitant ligamentous instability\u002Frupture\n* Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact)\n* Requirement for cartilage invasive treatment (debridement accepted)\n* Osteoarthritis at index knee joint\n* Leg axis deviation over 3° valgus or 4° varus\n* Claustrophobia (contra-indication for the MRI)\n* Women who are pregnant or breast feeding or intention to become pregnant during the study\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability of the patient to follow the study procedures, e.g. language problems, psychological disorders, dementia, etc.","ALL","18 Years","50 Years",{"count":76,"type":77},107,"ESTIMATED","INTERVENTIONAL",[80],"NA","The purpose of this clinical study is to compare the outcomes of two surgical techniques for reconstruction of the anterior cruciate ligament (ACL) after a single, primary ACL rupture.\n\nThe main question to be answered is:\n\n\\- Does less widening of the tibial tunnel occur when a bone\u002FPlatelet rich plasma (PrP) composite material is placed directly into the tibial tunnel after fixation of the implant (experimental group) compared to the same surgery without the use of the composite material (control group)?\n\nParticipants will be randomized into one of the two groups and they will not know which group they belong to. After 12 months they will undergo CT, MRI, medical examination and functional knee testing. They will have a further medical examination and functional knee testing at 24 months. Patient Reported Outcomes will be collected before surgery, 6, 12 and 24 months after surgery.",[83],"Anterior Cruciate Ligament Tear",[85,86,87],"Anterior Cruciate Ligament Reconstruction","Platelet-Rich Plasma","Bone Tunnel Widening","2024-01-26",{"date":90,"type":91},"2024-01-29","ACTUAL",{"date":93,"type":77},"2024-01",{"date":95,"type":77},"2027-08",{"name":5,"class":6},1]