[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aseptic-loosening-of-prosthetic-joint\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aseptic-loosening-of-prosthetic-joint":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,82,103],{"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":4,"briefSummary":22,"conditions":23,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100641087","post-market-clinical-follow-up-pmcf-study-evaluating-the-safety-and-efficacy-of-tpmed-revision-hip-prosthesis-system-100641087",false,"NCT07653295","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System","A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Male or female participants,\n* Participants who have undergone Revision Hip Arthroplasty (either total revision or partial component revision) for any indication (such as a documented joint failure or prosthesis-related clinical complication),\n* Participants in whose revision procedure the Tıpmed™ Revision Hip Prosthesis System components were utilized,\n* Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship),\n* Participants who have voluntarily signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Subjects currently participating in any other interventional clinical trial.","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants undergoing revision hip arthroplasty. The study aims to gather real-world clinical evidence on the 24-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.",[24,25,26,27,28,29],"Revision Hip Arthroplasty","Aseptic Loosening of Prosthetic Joint","Prostheses-related Infections","Joint Instability","Periprosthetic Fractures","Prosthesis Failure",[31,24,32,33,34],"Hip Prosthesis","Revision Hip Prosthesis","Post-Market Clinical Follow-Up (PMCF)","Harris Hip Score (HHS)","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2024-03-12",{"date":43,"type":20},"2029-03-31",{"name":45,"class":46},"TIPMED Medical Device Manufacturing Ltd. Co.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100576207","phase-4-the-use-of-cck-vs-ps-in-revision-tkas-100576207","NCT06782295","The Use of CCK vs PS in Revision TKAs","A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty","Inclusion criteria:\n\n* Patients between 18-80 years of age\n* Patients who are undergoing both femoral and tibial component revisions, or isolated femoral component revisions with a retained tibial component that is compatible with PS or CCK bearings\n* Patients who are at least 6-weeks out from primary TKA surgery, with complete pre-operative and post-operative knee radiographs obtained at standard of care perioperative visits (AP\u002Flateral and patellar views)\n* Patients undergoing rTKA for indications including aseptic component loosening, flexion or extension coronal or sagittal instability, component malalignment, arthrofibrosis, patellar maltracking, reimplantation following single or two-stage exchange revision for prosthetic joint infection or bearing surface wear when femoral or tibial component revision is indicated.\n* The use of revision total knee arthroplasty systems which have PS and CCK bearing options including different degree options of coronal and rotational constraint (to be individually randomized per constrained option):\n* Zimmer Biomet Persona, NexGen, or Vanguard\n* Smith and Nephew Legion\n* DJO \u002F Enovis Empowr\n* Stryker Triathlon\n* Link SymphoKnee\n* Depuy Attune sion Criteria:\n\nExclusion Criteria:\n\nPatients undergoing rTKA with a hinged implant, or pre-operatively determined to require CCK bearing rTKA, \\> 80 years of age, or those requiring rTKA less than 6-weeks from the primary TKA,\n\nPatients undergoing rTKA for bearing exchange only rTKA, isolated tibial component rTKA\n\nPatients with pre-operative diagnosis of extensor mechanism disruption or collateral ligament incompetence or with a compromised soft tissue envelope requiring pre-pre-operative plastic surgery evaluation and planned soft tissue coverage.\n\n\\-",{"count":55,"type":20},170,"INTERVENTIONAL",[58],"PHASE4","This study aims to compare the clinical impact of Constrained Condylar versus Posterior Stabilized Knee (PS) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty.",[25,61,62,63,64],"Instability of Prosthetic Joint","Reimplantation for Periprosthetic Joint Infection","Femoral Revision Indicated","Tibial Component Revision",[66,67,68,69,70],"revision total knee replacement","cck","ps","coronal instability","sagittal instability","2025-11-13",{"date":73,"type":39},"2025-11-14",{"date":75,"type":39},"2025-07-01",{"date":77,"type":20},"2038-07-01",{"name":79,"class":80},"Rush University Medical Center","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100571733","artificial-intelligence-to-detect-early-total-knee-replacement-implant-failure-100571733","NCT06724094","Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure","Using Machine Learning to Detect and Predict Loosening NexGen Total Knee Replacement","Inclusion Criteria:\n\n* Had a NexGen TKR between 2003 and 2022.\n\nExclusion Criteria:\n\n* Below 18 yrs old.\n* Revision surgery for any reason other than aseptic loosening\n* patients who have not had a revision but who do not have a well functioning TKR.",{"count":90,"type":20},2105,"The goal of this trial is to investigate whether Machine Learning (ML) can be used to detect small degrees of loosening, lucent zones, or any other changes on radiographs that might predict early failure following NexGen total knee replacement.\n\nResearchers will identify plain AP and lateral plain film radiographs from two groups of patients. Those who has NexGen total knee replacements (TKRs) that went on to failure, and those who has well performing TKRs. Radiographs from these two groups will be labelled as 'failure' and 'well performing' and will be processed through a machine learning algorithm.\n\nThe algorithm will be successful if it is able to detect a NexGen TKR that went on to failure or went on to perform well. This will be determined by using a test set.\n\nThe population will be adults who had the recalled a NexGen Total Knee Replacement with a standard tibial tray. It will include adults only, who has the TKR at University Hospitals Southampton between 2003 and 2022.\n\nFailure will be defined as revision of tibial or femoral components which is likely due to aspectic loosening. It will exclude washouts, exchange of poly, peri-prosthetic fractures, microbiologically confirmed infection.\n\nWell performing TKRs will be defined as patients who have had their TKR in situ for 10 years and have reported no significant symptoms.",[25],"NOT_YET_RECRUITING","2025-05-12",{"date":96,"type":39},"2025-05-13",{"date":98,"type":20},"2025-08",{"date":100,"type":20},"2025-12",{"name":102,"class":80},"University Hospital Southampton NHS Foundation Trust",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":56,"phases":113,"briefSummary":115,"conditions":116,"keywords":121,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100580631","digital-knee-study-adequately-diagnosing-total-knee-arthroplasty-loosening-by-evaluating-the-atmoves-knee-system-in-a-routine-clinical-setting-100580631","NCT06839807","DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting","Adequately Diagnosing Total Knee Arthroplasty Loosening: A Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting","DigitalKnee","Inclusion Criteria:\n\n* Age 18 years or older.\n* Subjects must have underwent either unilateral or bilateral TKA surgery.\n* Aseptic loosening is one of the differential diagnoses of the treating orthopaedic surgeon\n* The treating Orthopaedic Surgeon is uncertain of the diagnosis after anamnesis, physical examination and conventional x-ray.\n* The surgeon wants additional examinations or additional imaging to arrive at the diagnosis and proposal for treatment.\n* Subjects must be capable of giving informed consent and must be willing to undergo examination with the AtMoves Knee System.\n\nExclusion Criteria:\n\n* A clear other cause for complaints other than aseptic loosening (e.g. septic loosening, neuropathic pain, non-consolidated peri-prosthetic fracture of the bone around the TKA)\n* Surgical interventions of the index knee in the year prior to the start of the complaints associated with TKA loosening.\n* Posttraumatic or congenital deformation of the leg for which the loading device does not fit.\n* Pregnancy or suspected pregnancy.\n* Unable or unwilling to understand or sign the informed consent for this study and to undergo examination with the AtMoves Knee System.",{"count":112,"type":20},124,[114],"NA","The goal of the clinical trial is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic loosening in patients with a knee prosthesis. The main question it aims to answer is:\n\nDoes the use of the AtMoves Knee System reduce the percentage of failed outcomes? A \"failed outcome\" is defined as a change in the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS-PS) that is lower than the minimal clinically important difference at 12 months.\n\nResearchers will compare two groups: The first group will undergo an additional CT scan using the AtMoves Knee System. The second group will not undergo these scans. Both groups are allowed to undergo additional diagnostic measures. Researchers will compare the percentage of \"failed outcomes\" between these groups.\n\nDuring the one-year follow-up, participants in both groups will be asked to fill out questionnaires.",[117,25,118,119,120],"Aseptic Loosening","Aseptic Loosening of Orthopaedic Hardware","Knee Arthroplasty, Total","Total Knee Arthroplasty (Replacement)",[122,123,124,125,126],"Aseptic loosening of total knee prosthesis","Aseptic loosening","Total knee arthroplasty","Aseptic loosening of prosthetic joint","Knee arthroplasty","2025-02-17",{"date":129,"type":39},"2025-02-21",{"date":131,"type":20},"2025-02",{"date":133,"type":20},"2026-06",{"name":135,"class":80},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",7]