[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557791":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":61,"collaborators":33,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":33,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":33,"overallStatus":50,"whyStopped":33,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Internal Brace","EXPERIMENTAL","Patients will undergo ACL Reconstruction (ACLR) with an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.",[13,14],"Device: Arthrex Internal Brace","Procedure: ACL Reconstruction",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard ACLR","ACTIVE_COMPARATOR","Patients will undergo ACLR without an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Arthrex Internal Brace","The Arthrex Internal Brace method for ACL reconstruction consists of suture tape used to reinforce the ACL during surgery. This suture tape is secured in place with bioabsorbable anchors that gradually degrade within the body over time.",[9],[27],"AR-1593-BC",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","ACL Reconstruction","All patients will undergo ACL reconstruction (ACLR) with or without an internal brace. ACLR technique will be standardized to standard anteromedial (AM) portal femoral drilling to ensure consistency between surgeons.",[9,16],null,[35],{"name":36,"affiliation":5,"role":37},"Michael J. Alaia, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"Sangmin Lee","CONTACT","201-835-9117","sangmin.lee3@nyulangone.org",{"name":45,"role":41,"phone":46,"phoneExt":33,"email":47},"Kobe Rodney","347-988-9129","kobe.rodney@nyulangone.org",[49],{"facility":5,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":33},"RECRUITING","New York","10016","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-74.00597,40.71427,{"lat":59,"lon":58},{"type":62,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100557791","effect-of-internal-brace-on-outcomes-following-acl-reconstruction-with-btb-autograft-100557791",false,"NCT06542705","Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft","Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients undergoing ACLR with BTB autograft\n* Patients ages 18-35, inclusive\n* Ability to undergo standard rehab protocol and full, painless range of motion at the time of surgery of their operative knee\n\nExclusion Criteria:\n\n* Osteoarthritis defined by Kellgren-Lawrence grade 2 or higher on preoperative weightbearing radiographs\n* Significant chondral injury as defined by grade 3-4 lesion greater than 2cm2\n* History of autoimmune or inflammatory disease\n* Prior ipsilateral knee ligament surgery or multi-ligament knee injury\n* Concomitant Lateral extra-articular tenodesis (LET) procedure\n* History of contralateral ACL surgery\n* Younger than 18 years of age\n* Older than 35 years of age","ALL","18 Years","35 Years",{"count":74,"type":75},90,"ESTIMATED","INTERVENTIONAL",[78],"NA","The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with bone-tendon-bone autograft with and without internal bracing.",[30],"2026-03-03",{"date":83,"type":84},"2026-03-05","ACTUAL",{"date":86,"type":84},"2025-03-17",{"date":88,"type":75},"2029-03",{"name":5,"class":6},1]