[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anterior-talofibular-ligament\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anterior-talofibular-ligament":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":5},"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",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100623781","biobrace-in-arthroscopic-brostrom-lateral-ankle-ligament-repair-100623781","NCT07401095","BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair","Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study","Inclusion Criteria:\n\n1. At least 18 years of age at the time of surgery.\n2. Able to read, understand and sign the informed consent form.\n3. Willing to be available to attend each protocol required visit and complete the study required questionnaires.\n4. Scheduled to undergo primary, arthroscopic Brostrom repair.\n\nExclusion Criteria:\n\n1. Previous Brostrom surgery.\n2. Concomitant procedures that would change the post operative course\u002Frecovery (i.e. total ankle replacement, OCD repair, foot\u002Fankle osteotomies) as determined by the Investigator.\n3. Currently participating or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator.\n4. History of non-compliance with medical treatment or clinical trial participation.\n5. The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up.\n6. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.\n7. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.\n8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)",{"count":57,"type":21},40,[24],"The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.",[30,27,31,61,29,62,32],"Anterior Talofibular Ligament Injury","Brostrom",[64,65,66,30,27,67,32,68],"BioBrace","The BioBrace Implant","BioBrace Implant","CONMED","Ankle Injury","2026-02-10",{"date":71,"type":41},"2026-02-12",{"date":73,"type":41},"2025-12-08",{"date":75,"type":21},"2028-12",{"name":77,"class":48},"Hancock Orthopedics",1]