[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Symbios Orthopedie SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"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":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100564373","post-market-observational-study-of-the-harmony-evolution-implants-and-instruments-100564373",false,"NCT06628336","Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments","Inclusion Criteria:\n\n* Subjects of 18 years of age and older\n* Each subject who is willing to give informed consent\n* Clinically indicated for a Total Hip Replacement\n* Women of childbearing age who are not pregnant and do not expect to become pregnant within 12 months. A pregnancy test should be performed for women of childbearing age\n* Geographically stable and willing to return to the implanting site for all follow-up visits\n\nExclusion Criteria:\n\n* Acute or chronic, local or systemic infection\n* Muscular, neurological, psychological or vascular deficits\n* Poor bone density and quality likely to affect implant stability (severe osteoporosis)\n* Any concomitant condition likely to affect implant integration or function\n* Allergy or hypersensitivity to any of the materials used\n\nSpecific:\n\n• The HARMONY® Evolution Standard stem size 8 shall not be implanted in subjects weighing more than 70 kg.","ALL","18 Years","99 Years",{"count":19,"type":20},264,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR.\n\nThe objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score \\> 15 points) \\& safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years).\n\nThe endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.",[24],"Total Hip Replacement",[26,27,28],"HARMONY","THR","Prosthesis","RECRUITING","2024-10-03",{"date":32,"type":33},"2024-10-04","ACTUAL",{"date":35,"type":33},"2023-10-11",{"date":37,"type":20},"2035-03-11",{"name":39,"class":40},"Symbios Orthopedie SA","INDUSTRY",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100485968","a-post-market-observational-origin-cr-clinical-study-100485968","NCT05607966","A Post-market Observational ORIGIN® CR Clinical Study","Inclusion Criteria:\n\n* Male and female over 18 years of age\n* Each patient who is willing to give informed consent.\n* Clinically indicated for a total knee replacement\n* Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age\n* Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.\n\nExclusion Criteria:\n\n* Acute or chronic, local or systemic infection\n* Muscular, ligamental, neurological, psychological or vascular deficits\n* Bone destruction or poor bone quality likely to affect implant stability (requiring a femoral and\u002For a tibial stem and\u002For a thick insert)\n* Any concomitant condition likely to affect implant integration or function\n* Allergy or hypersensitivity to any of the materials used\n* For devices in CoCrMo (ISO 5832\u002F4): renal and hepatic impairment\n* Hip Knee Ankle (HKA) angle \\\u003C 165° or \\> 195°\n* Severe collateral ligaments deficiency (requiring a more constrained prosthesis)\n* Posterior cruciate ligament deficiency\n* Major anatomical deformities\n* Severe flexion contracture or severe recurvatum\n* Revision of a partial or total knee prosthesis\n* Non-extractible material (e.g. screws, plate, intramedullary nail, osteosynthesis material…) which can create a conflict with any component of the prosthesis\n* Distal and\u002For posterior and\u002For anterior femoral bone loss which exceeds the femoral component thickness\n* Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert)\n* Bone degradation requiring an anchoring stem for femoral component",{"count":49,"type":20},199,"The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year post procedure.\n\nThe hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® CR.",[52],"Total Knee Replacement",[54,55,28],"ORIGIN","TKA",{"date":57,"type":33},"2024-10-08",{"date":59,"type":33},"2024-07-10",{"date":61,"type":20},"2028-02",{"name":39,"class":40},2,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100418425","origin-vs-vanguard-ps-observational-study-100418425","NCT04728542","ORIGIN® vs. VANGUARD® PS Observational Study","A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.","Inclusion\u002Fexclusion criteria",{"count":72,"type":20},140,"The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.",[75,76,77],"Arthroplasty","Replacement","Knee",[75,77,28],{"date":32,"type":33},{"date":81,"type":33},"2021-03-25",{"date":83,"type":20},"2027-02",{"name":39,"class":40},1,""]