[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Societe dEtude, de Recherche et de Fabrication\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,58,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100525306","post-market-clinical-follow-up-for-total-knee-arthroplasty-system-madison-100525306",false,"NCT06120023","Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison","2022-07","Inclusion Criteria:\n\n* Male or female adults (≥ 18 years) covered by French social security system\n* Diagnosed with:\n\n  * Osteoarthritis (primary and secondary),\n  * Revision of a unicompartmental knee prosthesis.\n* Patient requiring a surgery and implantation of a Madison TKA (Total Knee Arthroplasty)\n* Patient physically and mentally able to comply with protocol, meet the follow-up visits as deemed by the investigator and fill in quality of life questionnaire.\n* Patient having signed a written informed consent\n\nExclusion Criteria:\n\n* Progressive, acute or chronic infection, local to the operative site or systemic that may affect the prosthetic joint,\n* Any loss of musculature or serious lesions of muscles, nerves and\u002For blood vessels deficiency, putting the affected limb at risk,\n* Lack of bone substance or inadequate bone quality on femoral or tibial surfaces, as it might compromise the stability of the prosthesis components,\n* Skeletal immaturity,\n* Pathologies that may compromise the functionality of the implant in any way (i.e. osteomyelitis, neuropathic joint),\n* Parameters incompatible with satisfactory long-term results (i.e. age, weight,\n* Neurological condition of the patient incompatible with the post-operative constraints associated with this type of intervention,\n* Known allergy to one of the implant components.\n* Severe obesity with or without comorbidities\n* Pregnant or nursing women,\n* Patients with a contraindication to radiography\n* Patients deprived of their liberty or hospitalised without their consent\n* Patients under legal protection (e.g. guardianship)","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","MADISON Total Knee Prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee.\n\nClinical data for MADISON Total Knee Prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.\n\nThus, in order to maintain compliance with the EU regulation (2017\u002F745) related to medical devices and following ISO 14\u002F155:2020, SERF has set up post-market clinical follow-up study (PMCF) to confirm safety and performance of Total Knee Arthroplasty system MADISON. This study is designed to cover the expected 15-years follow-up, to retrieve data according to implant feature (Posterior Stabilized or Ultra Congruent) or fixation method and to gather data related to the revision of partial knee prosthesis.\n\nThe primary objective of this study is to assess the clinical safety of MADISON total knee prostheses. The secondary objective is to evaluate the survival rates, the clinical performances and clinical benefits of MADISON total knee prosthesis.",[24],"Knee Arthropathy",[26],"total knee prosthesis","RECRUITING","2026-04-21",{"date":30,"type":31},"2026-04-22","ACTUAL",{"date":33,"type":31},"2023-10-17",{"date":35,"type":20},"2040-12-31",{"name":37,"class":38},"Societe dEtude, de Recherche et de Fabrication","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":39},"100506573","ambispective-multicentric-study-evaluating-uka-with-u-kneeuni-kroma-implants-100506573","NCT05876143","Ambispective Multicentric Study Evaluating UKA With U-Knee\u002FUni-Kroma Implants","Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee\u002FUni-Kroma Implants","Inclusion Criteria:\n\n\\- All patients using a U-Knee \u002F Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme.\n\nExclusion Criteria:\n\n* Patients who objected to participating in the study and the processing of their data\n* Patients unable to understand the surgeon's instructions to complete their questionnaires or perform postoperative follow-up\n* Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised.",{"count":48,"type":20},400,"This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee \u002F Uni-Kroma, in order to evaluate the performance of these implants.",[51],"Unicompartmental Knee Arthroplasty",{"date":30,"type":31},{"date":54,"type":31},"2023-01-01",{"date":56,"type":20},"2035-01-31",{"name":37,"class":38},{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100586591","clinical-performance-of-xpeo-e-liner-in-serf-dual-mobility-cups-100586591","NCT06917365","Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups","2024-01-XPEO-E","Inclusion Criteria:\n\n* Male or female adults.\n* Patient that needs to be implanted with a SERF total hip prosthesis.\n* Patient responding to IFU requirement.\n* Patient affiliated to French social security.\n* Patient who has provided a dated and signed informed consent form.\n\nExclusion Criteria:\n\n* Patient protected by a French legal measure (under legal protection, guardianship or curatorship).\n* Patient unable of expressing consent, according to the investigator.\n* Patient deprived of liberty or hospitalized against his consent.\n* Pregnant or breastfeeding patient.\n* Patient presenting a contraindication to the implantation of medical devices according to the instructions for use.\n* Patient with a contraindication to radiographic follow-up.\n* Patient not being, a priori, capable of respecting the schedule of follow-up visits, according to the investigator.\n* Patient unable to complete a self-questionnaire, according to the investigator.",{"count":66,"type":20},500,"XPEO-E liner is CE marked under MDD 93\u002F42\u002FCEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017\u002F745 (EU).\n\nXPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with the aim of improving quality of life and reducing pain by replacing a damaged joint.\n\nThe follow-up visits are established according to the current practice. Additional procedure will only consist on questionnaires that will be filled by the patient and\u002For the surgeons.",[69],"Total Hip Arthroplasty (THA)","2026-04-09",{"date":72,"type":31},"2026-04-13",{"date":74,"type":31},"2025-10-27",{"date":76,"type":20},"2032-03-31",{"name":37,"class":38},5,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":39},"100512729","hip-prospective-study-100512729","NCT05956236","Hip Prospective Study","Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses","Inclusion Criteria:\n\n* Male or female adults\n* Planned to be implanted with investigational medical devices per the IFUs:\n\n  * Implantation in skeletally mature adults (usually aged 60-65 and over), with an extremely painful and\u002For disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months\n  * Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer)\n  * For an intended purpose and indication listed in the IFUs\n* Affiliated to French social security\n* Who provided a dated and signed informed consent form\n\nExclusion Criteria:\n\n* Patient protected by a French legal measure\n* Patient not able to express his\u002Fher consent as deemed by the investigator\n* Patient deprived of liberty or hospitalized without consent\n* Pregnant or breastfeeding women\n* Patient contraindicated to investigational medical devices implantation per the IFUs\n* Patient contraindicated to radiographic follow-up\n* Patient a priori not able to meet the follow-up visits as deemed by the investigator\n* Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.",{"count":87,"type":20},5000,"In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017\u002F745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable.\n\nTherefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses.\n\nHiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.",[90],"Hip Arthropathy",[92,93],"Hip arthropalsty","Hip Prosthesis",{"date":95,"type":31},"2026-04-14",{"date":97,"type":31},"2023-04-24",{"date":99,"type":20},"2046-04",{"name":37,"class":38},""]