[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647447":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":67,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":25,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":100,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Standard Brostrom Repair (SBR)","Standard-of-care Brostrom repair",[12],"Procedure: Standard Brostrom Repair",{"label":14,"type":15,"description":16,"interventionNames":17},"Augmented Brostrom Repair (ABR)","EXPERIMENTAL","Brostrom repair augmented with BioBrace",[18],"Device: Brostrom repair with augmentation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Standard Brostrom Repair","Standard-of-care Brostrom repair for chronic lateral ankle instability",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","Brostrom repair with augmentation","Brostrom repair with BioBrace",[14],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Soheil Ashkani-Esfahani, MD MPH","CONTACT","510-850-6056","sashkaniesfahani@mgh.harvard.edu",[38,56],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-71.05977,42.35843,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":25,"email":55},"Gregory Waryasz, MD","781-487-4338","gwaryasz@mgb.org",{"facility":57,"status":39,"city":40,"state":41,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Brigham and Women's Hospital","02115",{"type":46,"coordinates":60},[48,49],{"lat":49,"lon":48},[63],{"name":64,"role":34,"phone":65,"phoneExt":25,"email":66},"Christopher Miller, MD","617-525-9382","cpmiller@mgb.org",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Soheil Ashkani Esfahani","Director, Foot & Ankle Research and Innovation Laboratory (FARIL); Assistant Professor, Department of Orthopaedic Surgery",[72],{"name":73,"class":74},"CONMED Corporation","INDUSTRY","100647447","brostrom-chronic-lateral-ankle-instability-repairs-augmented-with-biobrace-100647447",false,"NCT07708584","Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®","The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability","Inclusion Criteria:\n\n* Age 18-65 years\n* Chronic lateral ankle instability (\\>3 months) confirmed by clinical examination (positive anterior drawer test or talar tilt \\>10°) and imaging (stress X-ray or MRI).\n* No prior ankle surgery on the affected limb.\n* Willingness to follow postoperative visits and rehabilitation protocols and filling out the patient reported outcome measures (PROMs) forms.\n\nExclusion Criteria:\n\n* BMI\\>40\n* Significant secondary procedures done at the time of repair, including micro-fracture, or any other treatment of osteochondral lesions of the talus or tibia.\n* Concomitant deltoid ligament insufficiency.\n* Any worker's compensation case or any subject with a history of infection of the ankle predating the ankle repair. Current orthopedic issues, not related to the ankle, that prevented the patient from performing the functional tests.\n* Concomitant osteochondral lesions, significant degenerative changes, or severe varus\u002Fvalgus deformity, neuromuscular disorders or non-adherence concerns.\n* Pregnant\n* Diagnosis of Ehlers-Danlos Syndrome or other connective tissue \u002F hyperlaxity disorder.\n* Prior revision ankle ligament surgery on the affected limb (any revision Broström or lateral ligament reconstruction).","ALL","18 Years","65 Years",{"count":86,"type":87},75,"ESTIMATED","INTERVENTIONAL",[90],"NA","The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after open non-augmented Broström repair or open Broström repair augmented with the BioBrace Implant.",[93,94,95,96,97,98,99],"Lateral Ankle Instability","Chronic Lateral Ankle Instability","Brostrom Procedure","ATFL","Anterior Talofibular Ligament","Ankle","Bioinductive Implant",[93,101,99,96,97,95,102,98],"Brostrom Repair","Ankle Surgery","2026-08-18",{"date":105,"type":106},"2026-08-19","ACTUAL",{"date":108,"type":87},"2026-09",{"date":110,"type":87},"2028-06",{"name":5,"class":6},2]