{"doc_desc":{"title":"Cohorte sur l'adaptation de l'activit\u00e9 locomotrice chez les patients souffrant de coxarthrose","idno":"FRESH-PEF60148-fr","producers":[{"name":"Claire BONITHON-KOPP","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60148-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60148"},{"agency":"FReSH","code":"FRESH-PEF60148"}]},"title":"Cohorte sur l'adaptation de l'activit\u00e9 locomotrice chez les patients souffrant de coxarthrose","alternate_title":"LOCOX"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Claire;BONITHON-KOPP","PILabo":"CHU \/ CHU DIJON \/ INSERM CIE 1 UNIVERSIT\u00c9 DE BOURGOGNE","affiliationName":"chu","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"120001772","role":"pi id"},{"title":"SIREN","uri":"262100076","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"bonithon@u-bourgogne.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10","role":"sponsor id"},{"title":"SIREN","uri":"262100076","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10"},{"title":"SIREN","uri":"262100076"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Claire;BONITHON-KOPP","email":"bonithon@u-bourgogne.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0377z4z10","role":"organisation id","title":"ROR"},{"uri":"262100076","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"indication"},{"keyword":"proth\u00e8se totale de hanche"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"}],"topics":[{"topic":"Rhumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D012219"}]},{"topic":"Arthrose de la hanche","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/20048211","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00e9valuer le caract\u00e8re pronostique pour l'indication ult\u00e9rieure de proth\u00e8se totale de hanche de l'\u00e9valuation caract\u00e9ristiques de la marche chez des personnes souffrant de coxarthrose. Analyser l'adaptation de l'activit\u00e9 locomotrice en tant que crit\u00e8re pronostique de l'\u00e9volution ult\u00e9rieure de la maladie.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2014-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bourgogne Franche-Comt\u00e9']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Hommes ou femmes \u00e2g\u00e9s entre 45 et 75 ans  - souffrant de coxarthrose primitive d\u00e9finie selon les crit\u00e8res de l\u2019ACR ; - ayant pr\u00e9sent\u00e9 une douleur de hanche pendant au moins 1 mois au cours des 3 mois pr\u00e9c\u00e9dents ; - coxarthrose de stade radiologique ii, iii ou iv selon la classification de Kellgren et Lawrence ; - \u00e9tant \u00e0 m\u00eame de comprendre les ordres simples, les consignes de conditionnement, et de donner leur  consentement \u00e9clair\u00e9.   \",\n    \"clusion_E\": \"indication de pose de proth\u00e8se totale de hanche au moment de l\u2019inclusion ; - femme enceinte ou allaitante ; - Alzheimer ; - insuffisance respiratoire chronique avec manifestations cliniques ; - Parkinson ; - pathologie des moto-neurones ; - d\u00e9sordre musculo-squelettique majeur (autre que la coxarthrose) ; - diab\u00e8te s\u00e9v\u00e8re non stabilis\u00e9 ; - hypertension non stabilis\u00e9e ; - pouss\u00e9e inflammatoire de la coxarthrose ; - coxarthrose destructrice rapide ; - radiographie d\u2019\u00e9valuation de l\u2019\u00e9volution structurale de la maladie effectu\u00e9e il y a plus de 6 mois ; - pr\u00e9sence d\u2019une autre arthrose, ou d\u2019une autre affection ost\u00e9o-articulaire ou p\u00e9riarticulaire des membres inf\u00e9rieurs  avec, selon l\u2019opinion du patient, invalidit\u00e9 secondaire \u00e0 cette autre affection des membres inf\u00e9rieurs sup\u00e9rieure \u00e0  celle secondaire \u00e0 la coxarthrose ; - pathologie rachidienne \u00e0 l\u2019origine de troubles de la marche (radiculalgie, canal lombaire \u00e9troit, avec, selon l\u2019opinion du patient, invalidit\u00e9 secondaire \u00e0 cette affection rachidienne sup\u00e9rieure \u00e0 celle secondaire \u00e0 la coxarthrose) \"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es paracliniques (hors biologiques) : Exploration fonctionnelle']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers le patient Relance des sujets pour r\u00e9aliser les visites de suivi Contr\u00f4le de coh\u00e9rence et de donn\u00e9e manquante + monitoring des consentements Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"35 patients"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques \u00e0 d\u00e9terminer Utilisation possible des donn\u00e9es par des industriels \u00e0 d\u00e9terminer","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"30-07-2014","isContributorPI":"Non","contributorName":"Claire BONITHON-KOPP","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public 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saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Dijon"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion Informations recueillies lors de l'examen clinique : mesure de l'activit\u00e9 locomotrice + \u00e9valuation clinique de la coxtarthrose + m\u00e9dicaments pris","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}