[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FH ORTHO\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,71,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100513496","post-market-clinical-follow-up-of-hip-surgery-using-fh-ortho-company-medical-devices-100513496",false,"NCT05966220","Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.","Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices (FH ORTHO Company Hip Observatory).","HipFHOrtho","Inclusion Criteria:\n\n1. Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO Company for hip arthroplasty and traumatology, used in accordance with their approved Instruction For Use, in one of the centers participating in the Observatory.\n2. Patient is at least 18 years of age.\n3. Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally).\n4. In some countries, such as France, the patient will have to be socially insured to be included in the study.\n\nExclusion Criteria:\n\n1. An infection, or latent infection.\n2. A mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, failure of prosthetic fixation, or post-operative complications (except for the HIP\\&GO Double mobility cemented cup and, if applicable, the associated stems and heads when assembled together).\n3. Known Insufficient bone quality and\u002For bone stock.\n4. Known allergy to any component of the material listed on the product label.\n5. Metabolic diseases that could compromise bone regrowth.\n6. Metabolic and\u002For vascular treatment or disease that may compromise bone healing or consolidation.\n7. Drug dependency.\n8. Uncooperative patient unable to follow recommendations.\n9. Protected adult","ALL","18 Years",{"count":20,"type":21},800,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling).\n\nThe difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an arthroplasty. The observatory must also be able to cover devices used in surgery to repair osteoarticular trauma.\n\nThe observatory will be based on the principle of a \"dynamic\" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.\n\nTechnical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on phone\u002Ftablet\u002Fcomputer).",[27],"Hip Surgery",[29],"hip prosthesis, observatory","RECRUITING","2026-01-29",{"date":33,"type":34},"2026-02-02","ACTUAL",{"date":36,"type":34},"2024-01-08",{"date":38,"type":21},"2038-12",{"name":40,"class":41},"FH ORTHO","INDUSTRY",5,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100525649","performance-and-safety-evaluation-of-the-fhk-ck-knee-prosthesis-100525649","NCT06124482","Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis","Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis Indicated for the Treatment of Primary and Secondary First Line Gonarthrosis and Revision Arthroplasty - 2 Years Follow-up - A Pilot Study","FHK-CK","Inclusion Criteria:\n\n* Patient requiring knee arthroplasty for primary or secondary gonarthrosis:\n\n  \\* For primary intention arthroplasty: Patient with either\n  * major axial deviation,\n  * major peripheral failure or\n  * bone defect;\n\n    \\* For prosthesis revision surgery: Patient who have had a failed 1st implantation, with or without bone defects.\n* Patient able to understand and answer the questionnaires provided by the protocol;\n* Subject affiliated to a health insurance system or is a beneficiary;\n* Signed informed consent form (ICF) for participation to the research.\n\nExclusion Criteria:\n\n* Patient with an ongoing acute infection, outside knee to be operated;\n* Patient with a mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, prosthetic fixation failure or post-operative complications;\n* Patient with a known allergy to any of the components of the FHK®-CK implants (Nickel, Cobalt, Chromium);\n* Patient with a dependency (drug, alcohol,…) that could affect his\u002F her ability to comply with the protocol, at the investigator's discretion;\n* Patient requiring knee reconstruction;\n* Patient with any medically significant findings or significant history that may impact the safety, interpretation of results, and\u002F or participation of the subject in the clinical trial, as determined by the investigator;\n* Patient with an existing knee or hip prosthesis (outside knee to be operated) that may impact the evaluation of the FHK®-CK prosthesis;\n* Patient concurrently participating in another clinical trial or who has recently participated in another clinical trial for which the exclusion period has not been completed.\n* Vulnerable subjects :\n\n  * Pregnant, parturient, or breastfeeding women,\n  * Subject deprived of liberty, hospitalized without consent or admitted to a health or social establishment for purposes other than that of research,\n  * Minor,\n  * Adult under protective supervision (tutorship, curatorship),\n  * Subject not able to understand the subject information leaflet (e.g. for linguistic or psychiatric reasons) and\u002For to give informed consent",{"count":52,"type":21},92,[24],"The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery represents a large public health burden. In this context, FH ORTHO company develops FHK®-CK (prosthesis + ancillary equipment) which is a knee prosthesis for complex first intention and revision knee arthroplasty. This new medical device complements the FHK® standard first-line range (CE marked).\n\nThe FHK®-CK ancillary equipment were designed by expert knee surgeons and is simple, reliable and reproducible. It allows for maximum versatility while remaining compact.\n\nBy completing the FHK® range of first intention prostheses, the FHK®-CK allows the surgeon to be on the same level as the competitors by having a first intention and semi-constrained prosthesis. This prosthetic arsenal allows the surgeon to opt for the best solution for his patient so that he can regain mobility and a satisfactory quality of life. Also, in case of failure of the FHK® first-line prosthesis, it will provide the surgeon and the patient with a simple alternative to prosthesis replacement. As it has been developed in line with the first intention, inter-compatibility between the two systems is possible, which simplifies the surgical procedure and reduces the risks for the patient.",[56],"Total Knee Arthroplasty",[58,59,60,61],"Complex primary Total Knee Arthroplasty","Revision Total Knee Arthroplasty","Functional performance","Safety evaluation","2025-06-16",{"date":64,"type":34},"2025-06-19",{"date":66,"type":34},"2024-02-01",{"date":68,"type":21},"2028-02",{"name":40,"class":41},7,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100555420","fh-ortho-shoulder-observatory-100555420","NCT06511856","FH ORTHO Shoulder Observatory","Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices","Inclusion criteria:\n\n1. Any patient undergoing implantation of medical devices distributed by FH ORTHO SAS for shoulder arthroplasty and traumatology, used in accordance with their approved labelling, in one of the centres participating in the Observatory (retrospectively or prospectively)\n2. Patient is at least 18 years of age\n3. Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally) In some countries, such as France, the patient will have to be socially insured to be included in the study.\n\nExclusion criteria:\n\n1\\. Patient unable to participate in the study and\u002For complete the questionnaires 2. Refusal of patient participation\n\n\\-",{"count":79,"type":21},500,"OBSERVATIONAL","This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.\n\nIn this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.\n\nThis study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017\u002F745).\n\nIt therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit\u002Frisk of the medical devices concerned.\n\nThis study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.",[83,84],"Trauma","Arthropathy Shoulder","2024-07-15",{"date":87,"type":34},"2024-07-22",{"date":89,"type":34},"2022-09-08",{"date":91,"type":21},"2035-09-08",{"name":40,"class":41},3,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100532066","fh-ortho-sas-knee-observatory-100532066","NCT06207968","FH ORTHO SAS Knee Observatory","Post Market Clinical Follow-up of Knee Surgery Using FH ORTHO SAS Medical Devices (FH ORTHO SAS Knee Observatory)","Inclusion Criteria:\n\n* Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO SAS for knee arthroplasty and ligament reconstruction, used in accordance with their approved IFU, in one of the centers participating in the Observatory.\n* Patient is at least 18 years old at the time of surgery\n* Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally)\n* In some countries, such as France, the patient will have to be socially insured to be included in the study.\n\nExclusion Criteria:\n\nFor Arthroplasty:\n\n1. Infection, or latent infection\n2. A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery\n3. Insufficient bone stock for proper implant fixation\n4. It is the surgeon's responsibility to make sure that the patient does not have any known allergies to one of the compounds of the material listed on the product label.\n5. Metabolic diseases that might compromise bone regrowth\n6. Drug addiction\n7. Incomplete bone growth\n\nFor Ligament reconstruction:\n\n1. Infection, or latent infection\n2. A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery\n3. Insufficient bone stock\n4. Known allergies to one of the compounds of the material listed on the product label.\n5. Metabolic diseases that might compromise bone regrowth\n6. Uncooperative patient unable to follow recommendations\n\nAs the medical devices are used in real life according to their indications, pregnant or breastfeeding women are not excluded from the study, but for safety reasons it is not advisable to include them in the study.",{"count":102,"type":21},487,"The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved instructions for use (IFU).\n\nThe difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an knee arthroplasty. The observatory must also be able to cover devices used in ligament reconstruction surgery.\n\nThe observatory will be based on the principle of a \"dynamic\" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.\n\nTechnical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on smartphone\u002Ftablet\u002Fcomputer) when feasible.\n\nThe data to be collected and the different follow-up times are based on our state-of-the-art, clinical evaluation plans and clinical evaluation reports.",[105],"Knee Surgery","NOT_YET_RECRUITING","2024-02-21",{"date":109,"type":34},"2024-02-22",{"date":111,"type":21},"2024-05",{"date":113,"type":21},"2044-06",{"name":40,"class":41},10,""]