[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538705":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":33,"responsibleParty":51,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":71,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Marshall University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment",null,"These patients receive the surgery and are followed for two years for outcomes.",[13],"Procedure: Fertilized ACL",{"label":15,"type":10,"description":16,"interventionNames":10},"Control","These patients do not need and don't receive surgery and are followed for two years to compare to the surgery treatment group",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"PROCEDURE","Fertilized ACL","Fertilized ACL is an acl reconstruction with Bone marrow aspirate, demineralized bone matrix, and an internal brace.",[9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"chad d lavender, md","CONTACT","304-552-6514","doclav@gmail.com",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Kara Cipriani, NP","304-541-5316","cipriani6@marshall.edu",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Huntington","West Virginia","25755","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-82.44515,38.41925,{"lat":45,"lon":44},[48,49],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},{"name":50,"role":26,"phone":31,"phoneExt":10,"email":32},"Kara Cipriani, np",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[54],{"name":55,"class":56},"Arthrex, Inc.","INDUSTRY","100538705","return-to-play-after-acl-reconstruction-with-bone-marrow-aspirate-dbm-and-an-internal-brace-100538705",false,"NCT06294314","Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace","Return to Play After Anterior Cruciate Ligament Reconstruction With Bone Marrow Aspirate, Demineralized Bone Matrix, and an Internal Brace","Inclusion Criteria:\n\n* INCLUSION CRITERIA: All patients must meet the following criteria:\n\n  * Patients must be age 14-26 years old.\n  * Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation.\n  * Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity\n  * Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, and such pathology and treatment will be recorded.\n  * An understanding of the purpose of the study and providing written informed consent.\n\nExclusion Criteria:\n\n* EXCLUSION CRITERIA:\n\n  * Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),\n  * Patients who have undergone previous ACL reconstructive surgery.\n  * Patients who are currently pregnant or nursing.\n  * Patients who have a current infection at the operative site.\n  * Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.",true,"ALL","14 Years","26 Years",{"count":69,"type":70},450,"ESTIMATED","2 Years","OBSERVATIONAL","The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.",[75],"Anterior Cruciate Ligament Rupture","2024-02-27",{"date":78,"type":79},"2024-03-05","ACTUAL",{"date":81,"type":79},"2024-02-26",{"date":83,"type":70},"2028-07-01",{"name":5,"class":6},1]