[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588542":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"With postoperative brace (DonJoy Defiance Pro)","EXPERIMENTAL","Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace",[13],"Device: post-surgical functional bracing",{"label":15,"type":16,"description":17,"interventionNames":18},"Without post-surgical functional bracing","NO_INTERVENTION","Quadriceps Autograft ACL Reconstruction without the use of post-surgical functional bracing",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DEVICE","post-surgical functional bracing",[9],[25],"DonJoy Defiance Pro brace",[27],{"name":28,"affiliation":5,"role":29},"Brian Waterman, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Katherine Leonard","CONTACT","336-716-3952","Katherine.Leonard@Advocatehealth.org",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-80.24422,36.09986,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":52},"kmleonar@wakehealth.edu",{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100588542","bracing-and-reconstruction-of-the-anterior-cruciate-ligament-for-efficacy-trial-100588542",false,"NCT06942754","Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial","Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE-trial)","BRACE","Inclusion Criteria:\n\n* patients with unilateral complete ACL injury\n* patients involved in sports and the desire to return to sports\n* patients undergoing quadriceps autograft ACL reconstruction\n* must be 14 to 39 years old\n\nExclusion Criteria:\n\n* multiligamentous knee injuries defined as two ligaments requiring surgical stabilization\n* concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction\n* concomitant femoral, tibial, or patellar fracture(s)\n* patients with significant osteoarthritis\n* concomitant ipsilateral knee dislocation or patellar dislocation\n* significant lower leg malalignment requiring correcting osteotomies\n* prior ACL surgery, including contralateral knee\n* pregnancy during injury or surgery\n* unable to provide consent\n* prolonged use of prednisolone or cytostatics\n* comorbidities (e.g., muscular, neurological, vascular) that influence rehabilitation","ALL","14 Years","39 Years",{"count":67,"type":68},96,"ESTIMATED","INTERVENTIONAL",[71],"NA","Several attempts have been made to reduce these failure rates and improve return to sports rates in high-risk populations, and one of these approaches has been postoperative bracing. A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL reconstruction. Currently, however, there is no clear consensus on whether functional bracing following ACL reconstruction leads to lower failure rates, improved stability or better patient-reported outcomes when compared to ACL reconstruction without bracing.",[74],"Anterior Cruciate Ligament Injuries",[76,77,78],"Anterior Cruciate Ligament (ACL) reconstruction","postoperative bracing","functional bracing","2026-03-26",{"date":81,"type":82},"2026-04-01","ACTUAL",{"date":84,"type":82},"2025-09-11",{"date":86,"type":68},"2028-12",{"name":5,"class":6},1]