[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anterior-talofibular-ligament-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anterior-talofibular-ligament-injury":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100623781","biobrace-in-arthroscopic-brostrom-lateral-ankle-ligament-repair-100623781",false,"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)","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27,28,29,30,31,32],"ATFL","Lateral Ankle Instability","Anterior Talofibular Ligament","Anterior Talofibular Ligament Injury","Brostrom Procedure","Brostrom","Ankle",[34,35,36,26,27,37,32,38],"BioBrace","The BioBrace Implant","BioBrace Implant","CONMED","Ankle Injury","RECRUITING","2026-02-10",{"date":42,"type":43},"2026-02-12","ACTUAL",{"date":45,"type":43},"2025-12-08",{"date":47,"type":20},"2028-12",{"name":49,"class":50},"Hancock Orthopedics","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":51},"100579638","to-evaluate-the-effectiveness-of-the-use-of-a-novel-crosslinking-hyaluronan-hydrogel-on-the-prevention-of-the-adhesion-occurrence-after-anterior-talofibular-ligament-repair-surgery-100579638","NCT06826898","To Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery","A Prospective, Single-center, Randomized, Evaluator\u002Fsubject-blinded, Controlled Clinical Study: to Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery","Inclusion Criteria:\n\n1.1 Voluntarily participate and sign an informed consent form; 1.2 Age 18 to 60 years of male or female; 1.3 Patients experiencing lateral ankle pain discomfort, confirmed by MRI to have anterior talofibular ligament (ATFL) injury; 1.4 History of recurrent ankle inversion sprains three times or more, with no improvement after six months of conservative treatment, and scheduled for ATFL repair surgery; 1.5 Willing to comply with all follow-up requirements of the trial protocol.\n\nExclusion Criteria:\n\n2.1 Severe ankle osteoarthritis; 2.2 Patients with a history of ankle fracture or surgery; 2.3 Undergoing foot- or ankle-related treatments that may affect the trial results; 2.4 Presence of skin infection, skin defects, or need for skin grafting at the surgical site; 2.5 Uncontrolled chronic diseases, such as diabetes mellitus; 2.6 Presence of autoimmune diseases (such as Autoimmune Collagenopathy, rheumatoid arthritis), malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other conditions that may pose higher risks to patients in the trial; 2.7 Use of corticosteroids within the past 6 months, systemic corticosteroids within the past month, immunosuppressive drugs within the past 3 months, or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past week, or occasional use within 8 hours (patients using nasal\u002Finhaled corticosteroids may be considered for inclusion) ; 2.8 Clinically significant coagulation abnormalities or undergoing anticoagulant therapy within 10 days before surgery or currently taking anticoagulant drugs; 2.9 Known allergy to sodium hyaluronate or any components of medical devices;allergy to Gram-positive bacterial protein or streptococcal protein；or other severe allergic history deemed unsuitable for participation by the investigators; 2.10 Pregnant, lactating women, or women planning to become pregnant during the trial period; 2.11 Other conditions deemed unsuitable for participation by the investigators.","60 Years",{"count":61,"type":20},50,[23],"The goal of this clinical trial is to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery. With applying crosslinking hyaluronan hydrogel, the range of motion (ROM) of the ankle is expected to be better than sham group.",[29],"2025-02-10",{"date":67,"type":43},"2025-02-14",{"date":69,"type":20},"2025-03-01",{"date":71,"type":20},"2026-06-30",{"name":73,"class":50},"Talent Cro Inc."]