[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-traumatic-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-traumatic-arthritis":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,87,114],{"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":5},"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 Participants who have participated previously in this clinical trial and who have been withdrawn.\n5.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",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":65,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100245148","clinical-outcomes-study-of-the-nexel-total-elbow-100245148","NCT02469662","Clinical Outcomes Study of the Nexel Total Elbow","Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow","Inclusion Criteria:\n\n* Patient is 18 years of age or older.\n* Patient must have signed Institutional Review Board (IRB)\u002FEthics Committee (EC)-approved informed consent.\n* Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following:\n\n  * Elbow joint destruction which significantly compromises daily living activities\n  * Post-traumatic lesions or bone loss contributing to elbow instability\n  * Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis\n  * Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain\n  * Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis\n  * Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus\n* Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.\n\nAdditional Retrospective Arm Inclusion Criteria\n\n* Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit.\n* Patient information available for each retrospective patient must, at minimum, include preoperative demographic information, preoperative physical exam information, the index surgery operative report, and details of the devices implanted.\n\nExclusion Criteria:\n\n* Patient has a currently active or history of repeated local infection at the surgical site.\n* Patient has a current major infection distant from the operative site.\n* Patient has a history of prior sepsis.\n* Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.\n* Patient has significant ipsilateral hand dysfunction.\n* Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage.\n* Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and\u002For competitive sports.\n* Patient is a prisoner.\n* Patient is mentally incompetent or unable to understand what participation in the study entails.\n* Patient is a known alcohol or drug abuser.\n* Patient is anticipated to be non-compliant.\n* Patient is known to be pregnant.","18 Years",{"count":49,"type":19},134,"INTERVENTIONAL",[52],"NA","The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.",[55,56,57,58,59,60,61,62,63,64],"Elbow Joint Destruction","Post-traumatic Lesions","Ankylosed Joints","Advanced Rheumatoid Arthritis","Joint Instability or Loss of Motion","Acute Comminuted Articular Fracture of Elbow Joint Surfaces","Bone Loss Contributing to Elbow Instability","Bilateral Ankylosis From Causes Other Than Active Sepsis","Post-traumatic Arthritis","Degenerative Arthritis",[66,67,68,69,58,70,64,55,71,57,72,73,74,75,76],"Total Elbow Arthroplasty","TEA","Elbow Arthroplasty","Elbow Replacement","Post-Traumatic Arthritis","Post-Traumatic Lesions or Bone Loss","Acute Comminuted Articular Fracture","Significantly compromises daily living activities","Joint or soft tissue damage","Precludes less radical procedures","13-C3 fractures of the distal humerus","2025-10-28",{"date":79,"type":32},"2025-10-29",{"date":81,"type":32},"2015-06",{"date":83,"type":19},"2036-12",{"name":85,"class":39},"Zimmer Biomet",11,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":111,"locationsCount":113},"100608298","a-multi-center-study-assessing-the-safety-and-efficacy-of-the-legion-medial-stabilized-ms-insert-in-patients-undergoing-a-total-knee-arthroplasty-tka-100608298","NCT07199738","A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)","Inclusion Criteria:\n\n1. A). Prospective Subjects: Subject needing primary Total Knee Arthroplasty (TKA) due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.\n\n   OR\n\n   B). Retro-prospective Subjects: Subject has undergone primary TKA using the investigational product in the past 12 months to repair degenerative joint disease, post-traumatic arthritis or inflammatory arthritis and all the following conditions have been met:\n   * Pre-operative Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) has been obtained\n   * Post-operative radiographs have been obtained, or these can be collected prospectively in window per schedule of events\n   * 12-month post-operative KOOS JR have been obtained, or these can be collected prospectively in window per schedule of events\n2. Subject's treating clinician has decided the study device is suitable for the subjects TKA procedure and the study device is used in line with the applicable Instructions For Use (IFU) (listed in section 6).\n3. Subject agrees to consent and follow the prospective study visit schedule up to 10 years post-surgery (as defined in the study protocol and informed consent form) by signing the Independent Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved consent form.\n4. Subject is able to read, understand and communicate responses to Patient Reported Outcome Measure (PROM).\n5. Subject is 18-80 years old at the time of consent (inclusive).\n\nExclusion Criteria:\n\n1. Subject received revision TKA on the contralateral knee for a previously failed TKA, or Unicondylar Knee Arthroplasty (UKA).\n2. Subject has a Body Mass Index (BMI) ≥ 40 at pre-operative visit.\n3. Subject has ipsilateral hip arthritis resulting in flexion contracture of the hip joint.\n4. At the time of surgery, subject has one or more of the following arthroplasties that are not fully healed and\u002For well-functioning, in the opinion of the Investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; contralateral primary TKA or UKA.\n5. Subject has a condition that may interfere with the TKA survival or outcome (e.g., Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).\n6. Subject has a known allergy to one or more of the components of the study device.\n7. Any subject with hardware present in ipsilateral distal femur or proximal tibia.\n8. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.\n9. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days (30 days from operation\u002Fdosing).\n10. Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, ability to consent or complete the PROMs, including mental illness, drug or alcohol abuse.\n11. In the opinion of the Investigator, or site staff, Subject is at risk for lost to follow-up, or failure to return for scheduled visits.\n12. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures at the time of screening or the time of surgery.\n13. Subjects who have participated previously in this clinical trial and who have been withdrawn.\n14. Subject does not meet the indication or is contraindicated for TKA according to specific Smith+Nephew LEGION Knee System IFU.","80 Years",{"count":95,"type":19},144,"The purpose of this study is to assess the long-term safety and performance of the LEGION Medial Stabilized insert and to generate clinical evidence to support and maintain product registration in global markets.",[98,99,63],"Inflammatory Arthritis","Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis)",[101,24,102,103],"Primary TKA","post-traumatic arthritis","inflammatory arthritis","NOT_YET_RECRUITING","2025-09-26",{"date":107,"type":32},"2025-09-30",{"date":109,"type":19},"2025-11",{"date":83,"type":19},{"name":112,"class":39},"Smith & Nephew, Inc.",6,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":121,"enrollmentInfo":122,"targetDuration":124,"studyType":20,"phases":4,"briefSummary":125,"conditions":126,"keywords":135,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":5},"100494573","the-kinematx-midcarpal-total-wrist-arthroplasty-registry-100494573","NCT05719935","The KinematX Midcarpal Total Wrist Arthroplasty Registry","The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes","Inclusion Criteria:\n\n* one of the following diagnoses and planned (or previously completed) total wrist arthroplasty with the KinematX total wrist:\n\n  * osteoarthritis or post-traumatic arthritis\n  * scapholunate advanced collapse (SLAC\u002FSNAC wrist),\n  * inflammatory arthritis (rheumatoid, psoriatic, other),\n  * crystalline advanced collapse (SCAC),\n  * STT advanced collapse (STTAC),\n  * ulnar translocation,\n  * Kienbӧck disease,\n  * radial malunion\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* \\>85 years of age\n* Prisoners\n* Children\n* Pregnant women\n* Contraindications to receiving the KinematX:\n\n  * Local, distant or systematic acute or chronic soft tissue or bony infection\n  * Physiologically or psychologically compromised patient\n  * Active wrist synovitis or severe carpal bone erosion\n  * Suspected or documented metal allergy or intolerance\n  * Insufficient extensor tendons\n  * Inadequate skin, bone, neural or vascular status\n  * Severe carpal bone malalignment, displacement, absorption, neoplastic, or carpal bone pathology\n  * Sepsis\n  * Osteomyelitis\n  * Uncontrolled\u002Funtreated osteoporosis or metabolic bone disease\n  * Metabolic or endocrinologic bone disorders\n  * Osteomalacia\n  * Distant foci of infections which may spread to the implant site\n  * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram","85 Years",{"count":123,"type":19},50,"10 Years","The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study.\n\nThe main questions it aims to answer are:\n\n* What is the range of motion (flexion, extension, radial, ulnar, grip and pinch strength) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant.\n* What are the patient reported outcomes (PROMIS, PRWE, HSS wrist expectations) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant.\n* How do range of motion and patient reported outcomes change over the 10 years after total wrist replacement surgery?\n\nParticipants will be followed according to standard of care and preoperative and post-operative information for up to 10 years after surgery will be collected and entered into an electronic data base. Patients are eligible to enroll into the registry before or after they have had their wrist replacement surgery.",[127,128,129,130,131,132,133,23,98,24,134],"Scapholunate Advanced Collapse (SLAC)","Scapholunate Crystalline Advanced Collapse (SCAC)","Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC)","Carpal Tunnel Syndrome (CTS)","Kienbock's Disease of Adults","Radial Malunion","Ulnar Translocation","Scaphoid Non-union Advanced Collapse (SNAC)",[136,137],"Total wrist replacement","Total wrist arthroplasty","2023-11-13",{"date":140,"type":32},"2023-11-15",{"date":142,"type":32},"2021-04-26",{"date":144,"type":19},"2035-12",{"name":146,"class":39},"Extremity Medical"]