[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ankle-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ankle-arthritis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,64,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100636758","outcomes-of-surgical-treatment-using-a-custom-made-device-for-total-ankle-and-talar-replacement-in-the-management-of-severe-cases-of-bone-loss-or-bone-compromise-a-pilot-study-100636758",false,"NCT07569848","Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.","\\*\\*INCLUSION CRITERIA:\\*\\*\n\n1. Male or female patients aged between 35 and 75 years.\n2. Pathology of the tibiotalar joint requiring surgical intervention with prosthetic replacement.\n3. Severe cases of bone loss or talar bone compromise.\n4. Customisation performed at the Rizzoli Orthopaedic Institute.\n5. Signed informed consent for participation in the study.\n6. Patients must be prepared and motivated to comply with preoperative and postoperative investigations, rehabilitation protocols, follow-up schedules, and study questionnaires.\n\n\\*\\*EXCLUSION CRITERIA:\\*\\*\n\n1. Patients unable to understand or provide informed consent.\n2. Pregnant women.\n3. Body mass index (BMI) \\> 40.\n4. Refusal to sign the informed consent form for study participation.\n5. Substance abuse or psychological disorders that may interfere with adherence to rehabilitation and postoperative assessment protocols.\n6. Known hypersensitivity to device materials.\n7. Active or suspected latent infection in or around the affected ankle joint.\n8. Previous orthopaedic surgery on the lower limbs within the last year, or planned orthopaedic surgery within one year (excluding ankle replacement).\n9. Presence of neuromuscular or neurosensory deficits limiting the ability to assess device safety and efficacy.\n10. Diagnosis of systemic disease (e.g., systemic lupus erythematosus) or metabolic disorder (e.g., Paget's disease of bone) leading to progressive bone deterioration.\n11. Immunosuppression or excessive steroid therapy beyond physiological requirements (e.g., \\>30 days).\n12. Pregnant and\u002For fertile women.","ALL","35 Years","75 Years",{"count":19,"type":20},26,"ESTIMATED","36 Months","OBSERVATIONAL","On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use. This is a patient-specific talar spacer designed to completely replace the talus for the treatment of talar avascular necrosis. The implant represents an alternative to other surgical procedures that allows joint preservation.\n\nRecently, at the First Clinic of the Rizzoli Orthopaedic Institute, a prosthetic device has been developed that combines the tibial and meniscal components of a FAR-type ankle prosthesis (Adler Ortho) with a total talus replacement implant. Since the device is patient-specific and implanted using custom-made cutting guides, it reduces surgical invasiveness on surrounding bone structures as well as on ligamentous and tendinous structures, thereby preserving ankle function as much as possible.\n\nThe customization is based on a next-generation prosthetic model produced using additive manufacturing technology and featuring hypoallergenic properties, as it is made of a titanium alloy and treated with a nitriding process.\n\nThe aim of this study is therefore to evaluate the outcomes of this prosthetic device over time.",[25,26,27],"Arthrosis","Ankle Arthritis","Ankle Replacement","RECRUITING","2026-04-29",{"date":31,"type":32},"2026-05-06","ACTUAL",{"date":34,"type":32},"2022-02-11",{"date":36,"type":20},"2031-03",{"name":38,"class":39},"Istituto Ortopedico Rizzoli","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100576205","incidence-of-subtalar-joint-fusion-after-isolated-ankle-fusion-100576205","NCT06782269","Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion","Inclusion Criteria:\n\nAny patient who has had an isolated ankle fusion and is over the age of 18 years old.\n\nExclusion Criteria:\n\nParticipants younger than 18 years old.","18 Years","100 Years",{"count":50,"type":20},400,"It is important to know a truer incidence of the need for subtalar and midfoot fusions, following an isolated ankle fusion, in order to better inform our patients of the likelihood of needing further surgery in the future. It is also important to understand whether pre-existing radiological arthrosis is likely to lead to the need for a fusion in the future and also how important the alignment of the ankle joint, after a fusion, may influence that.\n\nThe aim of the study is to review the patients' notes and radiology who have had a previous isolated ankle fusion and then to see whether they subsequently required further surgery.",[26],"NOT_YET_RECRUITING","2025-04-07",{"date":56,"type":32},"2025-04-08",{"date":58,"type":20},"2025-06-01",{"date":60,"type":20},"2026-12-31",{"name":62,"class":63},"Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust","OTHER_GOV",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},"100545649","phase-4-intraosseous-vs-intravenous-vancomycin-administration-in-total-ankle-arthroplasty-100545649","NCT06384651","Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty","IOTAA","Inclusion Criteria\n\n* Patient is undergoing total ankle arthroplasty.\n* Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study\n* Age Range \\>18\n\nExclusion Criteria\n\n* Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from safely participating on the study.\n* BMI \\> 40.\n* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).\n* Inability to administer the IO infusion.\n* Patient refusal to participate.\n* Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C \\>7.5.\n* Immunocompromised or immunosuppressed patients (HIV, Hep C, end stage renal disease, dialysis, transplant, chemo\u002Fradiation treatment in last 6 months, medications).\n* Vulnerable populations",{"count":72,"type":20},40,"INTERVENTIONAL",[75],"PHASE4","The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).\n\nPrimary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.\n\nSecondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.",[78,26],"Infections","2025-01-22",{"date":81,"type":32},"2025-01-24",{"date":83,"type":32},"2024-12-03",{"date":85,"type":20},"2027-12",{"name":87,"class":39},"The Methodist Hospital Research Institute",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":15,"minAge":47,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":40},"100335637","total-ankle-replacement-clinical-and-radiological-outcomes-100335637","NCT03650010","Total Ankle Replacement: Clinical and Radiological Outcomes","Evaluation of Epidemiology and Radiological and Clinical Outcomes in Total Ankle Prosthesis","Inclusion Criteria:\n\n* Males and females\n* age ≥ 18 years at the time of surgery\n* patients who underwent ankle replacement surgery from January 2011 to March 2026\n\nExclusion Criteria:\n\n\\- age \\\u003C 18 years at the time of surgery",true,{"count":97,"type":20},1066,"This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically.",[26],"2018-08-27",{"date":102,"type":32},"2018-08-28",{"date":104,"type":32},"2016-05-11",{"date":106,"type":20},"2027-03-31",{"name":108,"class":39},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"]