[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533627":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":10,"locations":10,"responsibleParty":23,"collaborators":25,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":35,"eligibilityCriteria":36,"healthyVolunteers":31,"sex":37,"minAge":38,"maxAge":10,"enrollmentInfo":39,"targetDuration":10,"studyType":42,"phases":10,"briefSummary":43,"conditions":44,"keywords":46,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":10},{"fullName":5,"class":6},"LCA Pharmaceutical","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"ARTHRUM 2.5% single injection",null,[12],"Device: ARTHRUM 2.5%",[14],{"type":15,"name":16,"description":16,"armGroupLabels":17,"otherNames":10},"DEVICE","ARTHRUM 2.5%",[9],[19],{"name":20,"affiliation":21,"role":22},"DOMINIQUE BARON, MD","Centre de reeducation et de readaptation fonctionnelles en milieu marin de Trestel","STUDY_DIRECTOR",{"type":24,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[26],{"name":27,"class":28},"BIOSTATEM","UNKNOWN","100533627","assessment-of-safety-and-efficacy-of-arthrum-25-for-treatment-of-painful-osteoarthritis-of-the-knee-100533627",false,"NCT06228274","Assessment of Safety and Efficacy of ARTHRUM 2.5% for Treatment of Painful Osteoarthritis of the Knee","Measurement of the Real Life Efficacy of ARTHRUM 2.5% Health Product Single Injection in Patients Suffering From Knee Osteoarthritis","ART-ONE75","Inclusion Criteria:\n\n* Men or women aged over 40\n* Suffering from unilateral knee osteoarthritis confirmed radiologically less than six months ago and stage I, II or III according to KELGREEN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale and functional discomfort for at least three months\n* Patient able to understand the trial procedure and give his\u002Fher consent to take part, in writing\n* Patient geographically stable during the trial\n* Patient affiliated to the French social security regime or benefiting from such a French regime.\n\nExclusion Criteria:\n\n* Inflammatory arthritis\n* Progressive infectious condition of the knee being studied\n* Previous treatment with viscosupplementation for at least one year\n* Injection of corticoids into the knee studied for less than three months\n* Known hypersensitivity to hyaluronic acid or substances with similar activity\n* Anticoagulant treatment in progress\n* Insulin-dependent \u002F type I diabetes\n* Pregnant or breast-feeding women\n* Patient under guardianship or tutorship or under judicial protection\n* Patient currently taking part in another clinical research study.","ALL","40 Years",{"count":40,"type":41},218,"ACTUAL","OBSERVATIONAL","ARTHRUM 2.5% MONO-INJECTION as symptomatic treatment by joint injection extends the conservative therapeutic arsenal in Knee osteoarthritis.\n\nThe reduction of functional limits and disabilities induced by knee osteoarthritis as well as improvement of quality of life of patients is a public health need registered amongst the priorities established by the French law of 9 August 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.\n\nThis prospective, open, multi-centre trial of the real-life efficacy of ARTHRUM 2.5% aims to demonstrate the efficacy of a single joint injection of this treatment on pain, during 6 months, in the symptomatic treatment of patients suffering from Knee osteoarthritis",[45],"Knee Osteoarthritis",[47,45],"Hyaluronic Acid","COMPLETED","2024-01-18",{"date":51,"type":41},"2024-01-29",{"date":53,"type":10},"2013-03",{"date":55,"type":41},"2017-03",{"name":5,"class":6}]