[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480146":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":46,"responsibleParty":63,"collaborators":27,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":27,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":27,"enrollmentInfo":75,"targetDuration":27,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":27,"overallStatus":84,"whyStopped":27,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Columbia University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ACL reconstruction with internal brace augmentation (suture tape)","EXPERIMENTAL","This group will receive a standard ACL reconstruction using a BTB autograft with suture tape augmentation on the graft to strengthen it during the surgical procedure.",[13,14],"Procedure: ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)","Other: Standardized Rehabilitation Protocol",{"label":16,"type":17,"description":18,"interventionNames":19},"ACL reconstruction without internal brace augmentation","ACTIVE_COMPARATOR","This group will only receive a standard ACL reconstruction using a BTB autograft. No suture tape will be added to the graft during the surgical procedure.",[20,14],"Procedure: ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)","The ACL will be reconstructed using a participant's own patella tendon (BTB autograft), and the graft will be fortified by suture tape during the surgery in order to strengthen it.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)","The ACL will be reconstructed using a participant's own patella tendon (BTB autograft). The graft will not be fortified by suture tape in this group. It will be used as is without any modification.",[16],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Standardized Rehabilitation Protocol","Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy",[9,16],[37],{"name":38,"affiliation":39,"role":40},"David P Trofa, MD","Associate Professor of Orthopaedic Surgery","PRINCIPAL_INVESTIGATOR",[42],{"name":38,"role":43,"phone":44,"phoneExt":27,"email":45},"CONTACT","212 305 5974","dpt2103@cumc.columbia.edu",[47],{"facility":48,"status":27,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Columbia University Irving Medical Center","New York","10032","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-74.00597,40.71427,{"lat":57,"lon":56},[60,62],{"name":38,"role":43,"phone":61,"phoneExt":27,"email":45},"212-305-5974",{"name":38,"role":40,"phone":27,"phoneExt":27,"email":27},{"type":64,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100480146","anterior-cruciate-ligament-acl-reconstruction-with-bone-tendon-bone-autograft-with-versus-without-internal-bracing-100480146",false,"NCT05532189","Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing","ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes","Inclusion Criteria:\n\n* patients 12 and older\n* patients seen by the Columbia University Sports Medicine Service\n* patients diagnosed with a first time ACL injury by clinical exam and MRI\n\nExclusion Criteria:\n\n* previous knee surgery\n* concurrent knee fracture or ligamentous injury on ipsilateral knee\n* neuromuscular disorder involving lower limb\n* inability\u002F unwillingness to adhere to protocol\n* anesthesia contraindications\n* lost to follow up",true,"ALL","12 Years",{"count":76,"type":77},200,"ESTIMATED","INTERVENTIONAL",[80],"NA","There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.",[83],"ACL Tear","NOT_YET_RECRUITING","2025-09-16",{"date":87,"type":88},"2025-09-22","ACTUAL",{"date":90,"type":77},"2026-09",{"date":92,"type":77},"2032-09",{"name":5,"class":6},1]