[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532066":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":40,"responsibleParty":177,"collaborators":10,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":10,"eligibilityCriteria":185,"healthyVolunteers":181,"sex":186,"minAge":187,"maxAge":10,"enrollmentInfo":188,"targetDuration":10,"studyType":191,"phases":10,"briefSummary":192,"conditions":193,"keywords":10,"overallStatus":195,"whyStopped":10,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"FH ORTHO","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arthroplasty",null,"Knee prostheses are intended for patients suffering from functionally serious diseases of the knee causing daily disability that is insufficiently improved by medical treatment.\n\nThe functional diseases are among:\n\n* Knee osteoarthrosis\n* Osteonecrosis of the knee\n* Inflammatory disease\n* Patellofemoral arthritis\n\nThe patients having benefited from an arthroplasty will be followed for at least 15 years (until 20 years).",[13],"Device: Knee surgery with FH Ortho devices",{"label":15,"type":10,"description":16,"interventionNames":17},"Ligament reconstruction","Ligament reconstruction surgery should be considered for patient who have undergone a rupture of the anterior and\u002For posterior cruciate ligaments requiring partial or total reconstruction.\n\nThe patients having benefited from a ligament reconstruction will be followed for at least 5 years.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Knee surgery with FH Ortho devices","This clinical investigation is a real-life observatory designed to collect long-term clinical data on patients who have undergone knee joint replacement or knee ligament reconstruction.\n\nIn this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Charles KAJETANEK, MD","Hôpitaux Privés Rennais - Saint-Grégoire (Vivalto Santé) Institut Locomoteur de l'Ouest","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Cindy Lai","CONTACT","631315494","+33","c.lai@fhortho.com",{"name":37,"role":32,"phone":38,"phoneExt":34,"email":39},"Stephanie Lhuillier","607345965","s.lhuillier@fhortho.com",[41,58,72,89,103,112,126,140,154,168],{"facility":42,"status":10,"city":43,"state":10,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Clinique De La Chataigneraie","Beaumont","63541","France","FR",{"type":48,"coordinates":49},"Point",[50,51],3.08294,45.75165,{"lat":51,"lon":50},[54,57],{"name":55,"role":32,"phone":10,"phoneExt":10,"email":56},"Charles CASIN, MD","charles.casin@yahoo.fr",{"name":55,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":59,"status":10,"city":60,"state":10,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Clinique De La Miotte","Belfort","90002",{"type":48,"coordinates":63},[64,65],6.85385,47.64218,{"lat":65,"lon":64},[68,71],{"name":69,"role":32,"phone":10,"phoneExt":10,"email":70},"Pierre Bastien REY, MD","docteur.rey@docteur-rey.fr",{"name":69,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":73,"status":10,"city":74,"state":10,"zip":75,"country":45,"countryCode":46,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Polyclinique St Privat","Boujan-sur-Libron","34760",{"type":48,"coordinates":77},[78,79],3.24749,43.37082,{"lat":79,"lon":78},[82,85,86],{"name":83,"role":32,"phone":10,"phoneExt":10,"email":84},"Guillaume MIROUSE, MD","gmirouse@gmail.com",{"name":83,"role":28,"phone":10,"phoneExt":10,"email":10},{"name":87,"role":88,"phone":10,"phoneExt":10,"email":10},"Olivier BRINGER, MD","SUB_INVESTIGATOR",{"facility":90,"status":10,"city":91,"state":10,"zip":92,"country":45,"countryCode":46,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Clinique Du Val D'Ouest","Écully","69130",{"type":48,"coordinates":94},[95,96],4.77758,45.77437,{"lat":96,"lon":95},[99,102],{"name":100,"role":32,"phone":10,"phoneExt":10,"email":101},"Benoit GIRAUD, MD","dr.jgiraud@wanadoo.fr",{"name":100,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":104,"status":10,"city":105,"state":10,"zip":106,"country":45,"countryCode":46,"cosmosGeoPoint":107,"geoPoint":111,"contacts":10},"C.H. Raymond Poincare","Garches","92380",{"type":48,"coordinates":108},[109,110],2.18232,48.84226,{"lat":110,"lon":109},{"facility":113,"status":10,"city":114,"state":10,"zip":115,"country":45,"countryCode":46,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Hôpital Saint Vincent de Paul","Lille","59000",{"type":48,"coordinates":117},[118,119],3.05512,50.63391,{"lat":119,"lon":118},[122,125],{"name":123,"role":32,"phone":10,"phoneExt":10,"email":124},"Jean-Claude BOU, MD","bou.jean-claude@ghicl.net",{"name":123,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":127,"status":10,"city":128,"state":10,"zip":129,"country":45,"countryCode":46,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Hôpital Prive St Grégoire","Saint-Grégoire","35768",{"type":48,"coordinates":131},[132,133],-1.68579,48.15101,{"lat":133,"lon":132},[136,139],{"name":137,"role":32,"phone":10,"phoneExt":10,"email":138},"Charles Kajetanek, MD","charles.kajetanek@gmail.com",{"name":137,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":141,"status":10,"city":142,"state":10,"zip":143,"country":45,"countryCode":46,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Polyclinique De L'Europe","Saint-Nazaire","44615",{"type":48,"coordinates":145},[146,147],-2.2179,47.27506,{"lat":147,"lon":146},[150,153],{"name":151,"role":32,"phone":10,"phoneExt":10,"email":152},"Xavier CLÉMENT, MD","xavclement@hotmail.fr",{"name":151,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":155,"status":10,"city":156,"state":10,"zip":157,"country":45,"countryCode":46,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Medipole Garonne","Toulouse","31036",{"type":48,"coordinates":159},[160,161],1.44367,43.60426,{"lat":161,"lon":160},[164,167],{"name":165,"role":32,"phone":10,"phoneExt":10,"email":166},"Rodolphe LIMOZIN, MD","rodolphe@limozin.net",{"name":165,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":169,"status":10,"city":170,"state":10,"zip":171,"country":45,"countryCode":46,"cosmosGeoPoint":172,"geoPoint":176,"contacts":10},"Hôpital Privé Océane","Vannes","56000",{"type":48,"coordinates":173},[174,175],-2.76205,47.65688,{"lat":175,"lon":174},{"type":178,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100532066","fh-ortho-sas-knee-observatory-100532066",false,"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.","ALL","18 Years",{"count":189,"type":190},487,"ESTIMATED","OBSERVATIONAL","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.",[194],"Knee Surgery","NOT_YET_RECRUITING","2024-02-21",{"date":198,"type":199},"2024-02-22","ACTUAL",{"date":201,"type":190},"2024-05",{"date":203,"type":190},"2044-06",{"name":5,"class":6},10]