{"doc_desc":{"title":"French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study","idno":"FRESH-PEF73368-en","producers":[{"name":"Eugenie VALENTIN","affiliation":"INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73368-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73368"},{"agency":"FReSH","code":"FRESH-PEF73368"},{"agency":"NCT","code":"NCT02511158"}]},"title":"French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study","alternate_title":"FAST"},"study_authorization":{"agency":[]},"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 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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":"Dislocation or strain or sprain of joints or ligaments of knee","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1589820283","title":"CIM-11"}]}],"purpose":"In this study we will examine patients who have undergone anterior cruciate and\/or posterior cruciate ligament and\/or multi ligaments reconstruction to determine the rate of re-injury, contralateral tear and functional outcomes at least two years after surgery.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Participants enrolled in the FAST cohort by one of four surgeons and meeting eligibility criteria: \u2022 One ligament or multi-ligaments tear of the knee \u2022 Surgery reconstruction with any technique\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Automatic and scheduled checking (monthly)']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access not yet planned","sources":[],"target_sample_size":"[10000-20000[ individuals","response_rate":"500 persons per year"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Metadata-only access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"Access to data is restricted to medical director of clinical research program, surgeons and clinical research assitants of the "Fond de Dotation pour la Recherche Clinique en orthop\u00e9die et pathologie du 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