[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-lateral-ankle-instability\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-lateral-ankle-instability":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33],"Lateral Ankle Instability","Chronic Lateral Ankle Instability","Brostrom Procedure","ATFL","Anterior Talofibular Ligament","Ankle","Bioinductive Implant",[27,35,33,30,31,29,36,32],"Brostrom Repair","Ankle Surgery","RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-19","ACTUAL",{"date":43,"type":21},"2026-09",{"date":45,"type":21},"2028-06",{"name":47,"class":48},"Massachusetts General Hospital","OTHER",2]