{"doc_desc":{"title":"Adaptation of locomotor activity in patients suffering from hip osteoarthritis","idno":"FRESH-PEF60148-en","producers":[{"name":"Claire BONITHON-KOPP","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60148-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60148"},{"agency":"FReSH","code":"FRESH-PEF60148"}]},"title":"Adaptation of locomotor activity in patients suffering from hip osteoarthritis","alternate_title":"LOCOX"},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"total hip replacement"},{"keyword":"Health episodes"},{"keyword":"indication"}],"topics":[{"topic":"Rheumatology","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":"Osteoarthritis of hip","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/20048211","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"General objective: to assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip osteoarthritis for subsequent indications for total hip replacement. Analysis of the adaptation of locomotor activity as a prognostic criterion for future disease progression.","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":"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\": \"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\": \"Men and women aged between 45 and 75 years - suffering from primary hip osteoarthritis defined according to ACR criteria; - presented pain in the hip for at least one month in the preceding 3 months; - radiological stage II, III or IV hip osteoarthritis according to the Kellgren and Lawrence classification; - able to understand simple instructions, packaging instructions and give their informed consent.\",\n    \"clusion_E\": \" indication of total hip replacement at the time of inclusion; - pregnant or breast-feeding women; - Alzheimer's disease; - chronic respiratory insufficiency with clinical manifestations; - Parkinson's disease; - motor neuron disease; - major musculo-skeletal disorder (other than hip osteoarthritis); - severe non-stabilised diabetes; - non-stabilised hypertension; - hip osteoarthritis inflammation flare; - rapidly destructive hip osteoarthritis; - radiography to evaluate structural evolution of the disease done more than six months previously; - Presence of osteoarthritis in another joint, or another osteoarticular or periarticular disease of the lower limbs with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip osteoarthritis; - Spinal disease causing gait disturbance (radiculalgia, lumbar canal stenosis,\u2026 with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip osteoarthritis.).\"\n}","data_kind":"['Clinical data','Participant-reported health data','Paraclinical data (non-biological) : Function testing']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"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":"35 patients"},"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\"}]}"},"dataset_use":{"restrictions":"To be decided if data may be used by academic teams To be decided if data may be used by industrial teams","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"30-07-2014","isContributorPI":"No","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 (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered questionnaire: from paper questionnaire (manual input) and double data entry Interview: from paper questionnaire (manual input) with double data entry Clinical Examinations: handwritten (manual input) with double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Dijon"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}