{"study_desc":{"title_statement":{"idno":"FRESH-PEF73196-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73196"},{"agency":"FReSH","code":"FRESH-PEF73196"}]},"title":"Cohort of Patients Recovering from Periprosthetic Fracture or Total Hip Replacement","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Matthieu;EHLINGER","firstname":"Matthieu","lastname":"EHLINGER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04bckew43","role":"organisation id"},{"title":"SIREN","uri":"266700574","role":"organisation id"},{"uri":"0000-0002-5176-3433","role":"pi id","title":"ORCID"},{"uri":"08092185X","role":"pi id","title":"IdRef"}],"email":"Matthieu.ehlinger@chru-strasbourg.fr","affiliationName":"LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)","PILabo":"Strasbourg University Hospital","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":""}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Matthieu;EHLINGER","lastname":"EHLINGER","firstname":"Matthieu","type":"contact","email":"Matthieu.ehlinger@chru-strasbourg.fr","affiliationName":"LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04bckew43","role":"organisation id","title":"ROR"},{"uri":"266700574","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"periprosthetic fracture"},{"keyword":"recovery from total hip replacement"},{"keyword":"total hip replacement"},{"keyword":"orthopaedic registers"}],"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":"Fracture of bone following insertion of orthopaedic implant, joint prosthesis, or bone plate","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/984026612","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants: Access to care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"This study aims to clarify: (1) the relative frequency of this recovery; (2) risk factors and type of primary THR; (3) review procedures (4) morbidity and mortality of these surgical interventions.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2011-01-01"}],"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\":\"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\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"All patients monitored by a member of the French Society of Orthopaedic Surgery and Traumatology recovering from a periprosthetic fracture; total hip replacement (defined as a change in at least one component of primary total hip replacement).\",\"clusion_E\":\"Repeated recovery and recovery from hemiarthroplasty are excluded.\"}","data_kind":"['Clinical data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health care consumption and services"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"249"},"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\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"13-08-2015","lastUpdatedManual":"23-06-2016","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25172019"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":[],"otherSponsorType":[]},"governance":{"committee":""},"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":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Diagnosis that led to fitting a primary prosthetic device; age; sex and previous surgical procedures on the native hip. Age; approach; prosthesis fitting method; implant type; body mass index (BMI); American Society of Anesthesiologists (ASA) Score; Merle d'Aubign\u00e9 and Postel Score; Charnley category; Oxford-12 Hip Score and Devane activity score. Details on all intraoperative and postoperative surgical complications and medical complications observed within the first 3 months.","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"}