[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bioinductive-implant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bioinductive-implant":33},{"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":62,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100512998","maximal-repair-versus-bridging-reconstruction-with-biobrace-100512998","NCT05959733","Maximal Repair Versus Bridging Reconstruction with BioBrace®","Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis","Inclusion Criteria:\n\n* magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff\n* over 18 years of age\n\nExclusion Criteria:\n\n* glenohumeral osteoarthritis\n* Western Ontario rotator cuff score \\>60\n* uncontrolled diabetes (Hgb A1C \\>7%)\n* pregnant\n* local or systemic infection\n* inability to cooperate with and\u002For comprehend post-operative instructions\n* MRI proven non-vascular sites\n* poor nutritional state (Alb \\\u003C30 g\u002FL)\n* cancer\n* paralysis of the shoulder\n* contracture of the shoulder\n* patients unable to provide informed consent for the study",{"count":57,"type":21},60,[24],"The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.",[61,33],"Rotator Cuff Tears",[63,64,65,66,67,68,69],"shoulder","rotator cuff","clinical outcomes","radiographic outcomes","biomechanics","bridging reconstruction","rotator cuff repair","2025-02-14",{"date":72,"type":41},"2025-02-18",{"date":74,"type":41},"2023-12-07",{"date":76,"type":21},"2027-07-31",{"name":78,"class":48},"Nova Scotia Health Authority",1]