[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421625":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":76,"collaborators":80,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":56,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":56,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":50,"whyStopped":56,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University Hospital, Akershus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early ACL reconstruction","ACTIVE_COMPARATOR","Early ACL reconstruction is performed within 12 weeks after ACL injury and is followed by rehabilitation led by a physiotherapist. ACL surgical technique and rehabilitation is pragmatic according to the routines at the including centre.",[13],"Procedure: Early ACL reconstruction",{"label":15,"type":10,"description":16,"interventionNames":17},"Primary ACL rehabilitation","Primary ACL rehabilitation is active rehabilitaion led by a physiotherapist. Active rehabilitation will begin as early as possible after the ACL injury. The goal of rehabilitation is to stabilized the knee without an operation.\n\nACL reconstruciton is still an option after 6 months if the knee is unstable or do not allow adequat return to physical activity. If the patient sustain new knee injuries secondary to the ACL injury or has major instability, ACL reconstruction may be necessary before 6 months. The patients randomized to active rehabilitation will be routinely followed-up at his\u002Fher local hospital at 6 months.",[18],"Procedure: Active rehabilitation",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","ACL reconstruction followed by rehabilitation",[9],[25],"ACL surgery",{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Active rehabilitation","Non-operative treatment with active rehabilitation led by a physiotherapist with optional delayed surgery if indicated.",[15],[31],"Non-operative treatment, physiotherapy, physical therapy",[33],{"name":34,"affiliation":35,"role":36},"Rune Jakobsen, PhD\u002FMD","Akershus University Hospital, University of Oslo","STUDY_CHAIR",[38,43],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","92092973","+47","r.b.jakobsen@medisin.uio.no",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Guri Ekås, PhD\u002FMD","93617315","g.r.ekas@medisin.uio.no",[48,61],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":56,"contacts":57},"Orthopedic Department, Akershus University Hospital","RECRUITING","Lørenskog","Akershus","1478","Norway","NO",null,[58,60],{"name":59,"role":39,"phone":45,"phoneExt":41,"email":46},"Guri Ekås, PhD",{"name":34,"role":39,"phone":56,"phoneExt":56,"email":56},{"facility":62,"status":50,"city":63,"state":56,"zip":64,"country":54,"countryCode":55,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Orthopedic division, Oslo University Hospital","Oslo","0850",{"type":66,"coordinates":67},"Point",[68,69],10.74609,59.91273,{"lat":69,"lon":68},[72,74],{"name":73,"role":39,"phone":56,"phoneExt":56,"email":56},"Lars Engebretsen, PhD\u002FMD",{"name":75,"role":39,"phone":56,"phoneExt":56,"email":56},"Caroline Tveiten, MD",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"PRINCIPAL_INVESTIGATOR","Guri Ranum Ekås","Consultant, Orthopedic Surgeon, Researcher, Assistant professor (MD\u002FPhD)",[81,84,87,89],{"name":82,"class":83},"Norwegian National Knee Ligament Registry","UNKNOWN",{"name":85,"class":86},"Sorlandet Hospital HF","OTHER_GOV",{"name":88,"class":6},"Kristiansund Hospital",{"name":90,"class":6},"Asker & Baerum Hospital","100421625","how-to-best-treat-anterior-cruciate-ligament-injuries-100421625",false,"NCT04770233","How to Best Treat Anterior Cruciate Ligament Injuries","Improving the Treatment of Anterior Cruciate Ligament Tears in Norway With Register-RCTs - Who Should Have Surgery","Inclusion Criteria:\n\n* Patients who have sustained an acute ACL injury (must be possible to perform the \"early surgery\" treatment option within 12 weeks)\n* Age 16-50 years and skeletally mature\n* No previous surgery in the index knee or knee injury which influences rehabilitation\n* Patient capable to undergo both surgery and rehabilitation\n\nExclusion Criteria:\n\n• Elite athletes (Tegner 10) in pivoting sports and patients with additional knee injuries warranting repair","ALL","16 Years","50 Years",{"count":102,"type":103},328,"ESTIMATED","INTERVENTIONAL",[106],"NA","The project is a pragmatic registry-based RCT aiming to investigate ACL injury treatment. Study results will help fill knowledge gaps, facilitate shared decision making and strengthen patient treatment.\n\nIncluded patients will be randomized to (1) early ACL surgery followed by rehabilitation or (2) active rehabilitation with optional delayed surgery if indicated.\n\nRandomization and data collection is conducted through the Norwegian National Knee Ligament Registry (NNKLR) which is a well established population based ACL registry. Participation is based on informed consent to participate in the NNKLR and the registry-based RCT. The study uses the platform and outcome measures of the NNKLR to collect and measure data. The data will be stored as usual in the NNKLR, but RCT specific data will be exported for analysis and stored inTjenester for sensitive data (TSD). Data collected in NNKLR are: patient data (age, height, weight, activity level, smoking-and snuff habits), knee injury data (injury data, injury mechanism, additional knee injury), treatment (non-operative or ACL reconstruction, reoperation), surgical details (operation date, antibiotics, anti-coagulants, graft type and size, approach for femoral tunnel, additional injury and additional surgical procedure) and patient reported knee function at baseline, 2, 5 and 10 years. Also, x-rays and MRIs will be imported for included patients and stored in TSD.",[109],"Anterior Cruciate Ligament Injuries",[111,112,113,114,115,116,117],"acl","anterior cruciate ligament injury","anterior cruciate ligament rupture","anterior cruciate ligament tear","secondary meniscal tear","ACL reconstruction","ACL rehabilitation","2025-01-27",{"date":120,"type":121},"2025-01-28","ACTUAL",{"date":123,"type":121},"2021-04-29",{"date":125,"type":103},"2045-12",{"name":5,"class":6},2]