{"doc_desc":{"title":"\u00c9tude prospective de cohorte fran\u00e7aise sur la reconstruction du ligament crois\u00e9 ant\u00e9rieur","idno":"FRESH-PEF73368-fr","producers":[{"name":"Eugenie VALENTIN","affiliation":"INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73368-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73368"},{"agency":"FReSH","code":"FRESH-PEF73368"},{"agency":"NCT","code":"NCT02511158"}]},"title":"\u00c9tude prospective de cohorte fran\u00e7aise sur la reconstruction du ligament crois\u00e9 ant\u00e9rieur","alternate_title":"FAST"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"},{"name":"Autre"}]},"authoring_entity":[{"name":"Shahnaz;KLOUCHE","firstname":"Shahnaz","lastname":"KLOUCHE","type":"investigator","extlink":[{"title":"SIREN","uri":"790937023","role":"organisation id"}],"email":"","affiliationName":"FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT","PILabo":"Fonds Dotation pour la Recherche Clinique en orthop\u00e9die et pathologie du sport \/ Chirurgie orthop\u00e9dique","isContact":false},{"name":"Nicolas;LEFEVRE","firstname":"Nicolas","lastname":"LEFEVRE","type":"investigator","extlink":[{"title":"SIREN","uri":"790937023","role":"organisation id"}],"email":"docteurlefevre@gmail.com","affiliationName":"FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT","PILabo":"Fonds Dotation pour la Recherche Clinique en orthop\u00e9die et pathologie du sport \/ Chirurgie orthop\u00e9dique","isContact":true},{"name":"Eugenie;VALENTIN","firstname":"Eugenie","lastname":"VALENTIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02cnsac56","role":"organisation id"},{"title":"SIREN","uri":"180037020","role":"organisation id"}],"email":"eugenie@chirurgiedusport.com","affiliationName":"INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED)","PILabo":"","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT","extlink":[{"title":"SIREN","uri":"790937023","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT","extlink":[{"title":"SIREN","uri":"790937023"}]}]},"distribution_statement":{"contact":[{"name":"Yoann;BOHU","lastname":"BOHU","firstname":"Yoann","type":"contact","email":"dr.bohu@chirurgiedusport.com","affiliationName":"FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT","contactPointLabo":"","extlink":[{"uri":"790937023","role":"organisation id","title":"SIREN"}]},{"name":"Nicolas;LEFEVRE","lastname":"LEFEVRE","firstname":"Nicolas","type":"contact","email":"docteurlefevre@gmail.com","affiliationName":"FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT","contactPointLabo":"","extlink":[{"uri":"790937023","role":"organisation id","title":"SIREN"}]},{"name":"Eugenie;VALENTIN","lastname":"VALENTIN","firstname":"Eugenie","type":"contact","email":"eugenie@chirurgiedusport.com","affiliationName":"INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02cnsac56","role":"organisation id","title":"ROR"},{"uri":"180037020","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Ligament crois\u00e9 ant\u00e9rieur (LCA)"},{"keyword":"reconstruction du LCA"},{"keyword":"blessures sportives"}],"topics":[{"topic":"M\u00e9decine physique et de r\u00e9adaptation","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/38e57437-b2cc-4d26-a46e-c5b639c01e5f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010810"}]},{"topic":"Orthop\u00e9die et traumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4538836-ae58-4941-b544-50f53e979e20"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009985"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D014194"}]},{"topic":"Luxation, foulure ou entorse des articulations ou des ligaments du genou","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1589820283","title":"CIM-11"}]}],"purpose":"Dans cette \u00e9tude, nous examinerons les patients qui ont subi une reconstruction du ligament crois\u00e9 ant\u00e9rieur et\/ou du ligament crois\u00e9 post\u00e9rieur et\/ou de plusieurs ligaments afin de d\u00e9terminer le taux de nouvelle blessure, la d\u00e9chirure controlat\u00e9rale et les r\u00e9sultats fonctionnels au moins deux ans apr\u00e8s l'op\u00e9ration.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2032-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\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\": \"Crit\u00e8res d'\u00e9ligibilit\u00e9 : - D\u00e9chirure d'un ligament ou de plusieurs ligaments du genou - Chirurgie de reconstruction avec n'importe quelle technique\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['V\u00e9rification automatique et programm\u00e9e (mensuelle)']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Pas d\u2019acc\u00e8s","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"500 personnes par an"},"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 aux seules m\u00e9tadonn\u00e9es\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"L'acc\u00e8s aux donn\u00e9es est r\u00e9serv\u00e9 au directeur m\u00e9dical du programme de recherche clinique, aux chirurgiens et aux assistants de recherche clinique du Fond de Dotation pour la Recherche Clinique en orthop\u00e9die et pathologie du sport.","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":"17-10-2016","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[{"type":"","title":"","link":"doi: 10.1007\/s00167-013-2384-4"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":false},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Internet (e-CRF et auto-questionnaires), logiciel d'enqu\u00eate en ligne","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es perop\u00e9ratoires, scores objectifs du genou (IKDC, amplitude de mouvement)","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}