[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"total-ankle-replacement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:total-ankle-replacement":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100602053","a-prospective-post-market-clinical-follow-up-study-of-the-incompass-total-ankle-system-100602053",false,"NCT07118501","A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System","Inclusion Criteria:\n\n1. The participant must be willing and able to sign a written approved informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC)\n2. Participants must be males or non-pregnant females aged 21 years or older at the time of surgery;\n3. Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits.\n4. The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires.\n5. Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU).\n\nExclusion Criteria:\n\n1. Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;\n2. Participant is currently enrolled in or plans to enroll in any concurrent drug and\u002For device clinical investigation that, in the opinion of the Investigator, may confound results;\n3. Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44.\n4. Participants who have participated previously in this clinical trial and who have been withdrawn.\n5. Participant who is, or will be, inaccessible for follow-up\n6. Participant is pregnant or intends to become pregnant during the course of the study.\n7. Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.\n8. Participants requiring revision total ankle replacement of the ankle being considered for the study;\n9. Participants with a failed previous ankle surgery (e.g., takedown fusion)\n10. Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis;\n11. Participants with compromised vascularity that would inhibit blood supply to the operative site;\n12. Neuropathic arthropathy of the joint;\n13. Insufficient bone stock or bone quality that cannot provide adequate support of the device;\n14. Participants who have documented or suspected sensitivity to the implant materials.\n15. Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable\n16. Participant who routinely place excessive loads on their ankle as caused by activity and\u002For patient weight, per investigator discretion; or\n17. Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care.","ALL","21 Years",{"count":18,"type":19},200,"ESTIMATED","OBSERVATIONAL","The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period. The study will measure improvements in patient-reported information related to quality of life and pain following surgery. In order to do this, medical imaging (i.e. X-Rays, CT scans) which have been taken as part of routine care, will be reviewed. Any additional X-Rays conducted during the period of the research will also be reviewed.\n\nThe Incompass™ Total Ankle System has been cleared by the Food and Drug Administration (FDA). The products are already in use routinely in ankle replacement surgeries. No part of this study is experimental.",[23,24,25,26],"Post Traumatic Arthritis","Osteoarthritis","Total Ankle Replacement","Total Ankle Prosthesis",[25],"RECRUITING","2026-03-20",{"date":31,"type":32},"2026-03-24","ACTUAL",{"date":34,"type":32},"2026-02-06",{"date":36,"type":19},"2038-09-01",{"name":38,"class":39},"Stryker Trauma and Extremities","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":52,"studyType":20,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100523113","validation-of-the-italian-version-of-the-forgotten-joint-score-fjs-12-in-total-ankle-replacement-100523113","NCT06091397","Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement","Validation of the Italian Version of the Forgotten Joint Score (FJS-12) as a Patient-reported Outcome Measure in Total Ankle Replacement: a Study on an Italian Population","Inclusion Criteria:\n\n* Patients of either gender, aged between 25 and 80 years;\n* Patients who have undergone total ankle replacement surgery for tibio-tarsal joint pathology starting from 2018, as well as new patients on the waiting list.\n* Signed informed consent for participation in the study;\n* Patients who are prepared and motivated to attend the scheduled follow-up visits and complete the study questionnaires.\n\nExclusion Criteria:\n\n* Patients unable to understand or consent;\n* BMI \\> 40.\n* Refusal to complete the study consent form.\n* Substance abuse or psychological disorders that could interfere with the ability to comply with rehabilitation programs and postoperative assessments.\n* Known sensitivity to device materials.\n* Presence of an active or suspected latent infection in or around the affected ankle joint.","25 Years","80 Years",{"count":51,"type":19},120,"60 Months","The arthritic pathology of the tibio-tarsal joint has a prevalence of approximately 1% in the general population, and its incidence has been increasing over the years. Advanced-stage arthritis causes pain, impairs mobility, and has an extremely negative impact on patients' quality of life, resulting in significant social and economic costs. Unlike hip and knee arthritis, ankle arthritis is often secondary to traumatic events, affecting younger patients. An emerging treatment for severe ankle arthritis is ankle prosthetic replacement, and patient-reported outcome measures (PROMs) are increasingly used to assess patient outcomes. The study focuses on the validity and reproducibility of the Italian versione of the Forgotten Joint Score (FJS) in ankle prostheses, obtained through the translation-back-translation method, with a sample size of 120 patients.",[55,25,56],"PROMs","Italian Forgotten Joint Score","2024-07-31",{"date":59,"type":32},"2024-08-02",{"date":61,"type":32},"2022-07-01",{"date":63,"type":19},"2028-01",{"name":65,"class":66},"Istituto Ortopedico Rizzoli","OTHER",1]