{"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":[{"name":"CNIL"},{"name":"CPP"},{"name":"Other"}]},"authoring_entity":[{"name":"Shahnaz;KLOUCHE","firstname":"Shahnaz","lastname":"KLOUCHE","type":"investigator","extlink":[{"title":"SIREN","uri":"790937023","role":"organisation id"},{"uri":"250409623","role":"pi id","title":"IdRef"}],"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"},{"uri":"285321870","role":"pi id","title":"IdRef"}],"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":"Epidemiology France Portal (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":"Anterior Cruciate Ligament"},{"keyword":"ACL Reconstruction"},{"keyword":"Sport injuries"}],"topics":[{"topic":"Physical and Rehabilitation Medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/38e57437-b2cc-4d26-a46e-c5b639c01e5f"},{"title":"MeSH","uri":"D010810"}]},{"topic":"Orthopaedics and traumatology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4538836-ae58-4941-b544-50f53e979e20"},{"title":"MeSH","uri":"D009985 | 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":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Child (6 to 12 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002648\"}},{\"value\":\"Adolescent (13 to 18 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}},{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"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\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Paraclinical data (non-biological)','Paraclinical data (non-biological) : Imaging','Biological data','Socio-demographic data','Participant-reported health data']","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\"}]}","notes":""},"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 sport\"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"17-10-2016","lastUpdatedManual":"07-07-2025","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[{"type":"","title":"","link":"doi: 10.1007\/s00167-013-2384-4"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"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 and self-questionnaires) on websurvey software","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Peroperative data , objective scores of the knee (IKDC, range of motion)","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"}