[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385065":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":97,"collaborators":20,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":20,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":124,"whyStopped":20,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Fidia Farmaceutici s.p.a.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HYMOVIS Arm","EXPERIMENTAL","A treatment cycle consists of two injections administered at one week interval. For the purpose of this study, two treatment cycles of two injections of HYMOVIS® at baseline and 6 months will be performed per patient at V1 (Day 0), V2 (Day 7), V5 (Day 180) and V6 (Day 187).",[13],"Device: HYMOVIS",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","HYMOVIS","HYMOVIS is a clear hydrogel obtained by hydration of the HA-based derivative named HYADD4p5. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process.",[9],null,[22,35,44,53,58,70,79,88],{"facility":23,"status":20,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":20},"Service de Rhumatologie CHU Dinant-Godinne (Site Godinne)","Yvoir","Namur","5530","Belgium","BE",{"type":30,"coordinates":31},"Point",[32,33],4.88059,50.3279,{"lat":33,"lon":32},{"facility":36,"status":20,"city":37,"state":20,"zip":38,"country":27,"countryCode":28,"cosmosGeoPoint":39,"geoPoint":43,"contacts":20},"Service de Rhumatologie, CHU Brugmann","Brussels","1020",{"type":30,"coordinates":40},[41,42],4.34878,50.85045,{"lat":42,"lon":41},{"facility":45,"status":20,"city":46,"state":20,"zip":47,"country":27,"countryCode":28,"cosmosGeoPoint":48,"geoPoint":52,"contacts":20},"CHR Citadelle de Liège","Liège","4000",{"type":30,"coordinates":49},[50,51],5.56749,50.63373,{"lat":51,"lon":50},{"facility":54,"status":20,"city":46,"state":20,"zip":47,"country":27,"countryCode":28,"cosmosGeoPoint":55,"geoPoint":57,"contacts":20},"Service de Rhumatologie CHU Liège",{"type":30,"coordinates":56},[50,51],{"lat":51,"lon":50},{"facility":59,"status":20,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":20},"Service de Rhumatologie CHR Metz Thionville Hôpital Bel Air","Thionville","Thionville Cedex","60327 57126","France","FR",{"type":30,"coordinates":66},[67,68],6.16044,49.35994,{"lat":68,"lon":67},{"facility":71,"status":20,"city":72,"state":20,"zip":73,"country":63,"countryCode":64,"cosmosGeoPoint":74,"geoPoint":78,"contacts":20},"Hopital Edouard Herriot (Lyon)","Lyon","69003",{"type":30,"coordinates":75},[76,77],4.84789,45.74906,{"lat":77,"lon":76},{"facility":80,"status":20,"city":81,"state":20,"zip":82,"country":63,"countryCode":64,"cosmosGeoPoint":83,"geoPoint":87,"contacts":20},"Service de rhumatologie,RDC Hôpital Lariboisière","Paris","75010",{"type":30,"coordinates":84},[85,86],2.3488,48.85341,{"lat":86,"lon":85},{"facility":89,"status":20,"city":90,"state":20,"zip":91,"country":63,"countryCode":64,"cosmosGeoPoint":92,"geoPoint":96,"contacts":20},"Centre Hospitalier Nord Franche-Comté","Trévenans","10499",{"type":30,"coordinates":93},[94,95],6.86667,47.56667,{"lat":95,"lon":94},{"type":98,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100385065","evaluation-of-the-evolution-of-biological-and-imaging-markers-of-bone-and-cartilage-degradation-in-patients-with-knee-osteoarthritis-receiving-intra-articular-injections-of-a-hyaluronan-derivative-hymovis-100385065",false,"NCT04293861","Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS®","MOKHA","Inclusion Criteria:\n\n* Male or female between the age of 40 and 80 with BMI ≤ 40\n* Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee OA associated or not with femoropatellar knee OA\n\n  * Responding to clinical and radiological criteria of the American College of Rheumatology (ACR) (Appendix 1)\n  * Symptomatic for more than 6 months in the most painful knee\n  * Radiological Kellgren \\& Lawrence (K\\&L) II or III in radiographs from less than 12 months (Appendix 2)\n* Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40 (Appendix 3) with a washout period for Paracetamol and oral NSAIDs depending on the half-life of the drug (Appendix 4). The most painful knee is considered.\n* Able to follow the instructions of the study\n* Having signed an ICF\n\nExclusion Criteria:\n\nRelated to the OA pathology\n\n* Bilateral (except asymptomatic and grade I) OA of the knee\n* Radiological K\\&L grade I or IV (Appendix 2)\n* Chondromatosis or villonodular synovitis of the knee\n* Recent trauma (\\\u003C 1 month) of the knee responsible of the symptomatic knee\n* Acute inflammatory OA (KOFUS (Knee Osteoarthritis Flare Up Scale) score ≥ 7, Appendix 5)\n* Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis….\n* Inflammatory disease i.e. rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis\n* Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs, arteritis…..)\n* Presence of another joint (other than the target knee) affected by OA (confirmed in radiographs and symptomatic)\n\nRelated to treatments\n\n* Corticosteroids injection in the target knee in the last month before first injection\n* Hyaluronan injection in the target knee in the last 6 months before first injection\n* Arthroscopy and surgery in the target knee in the last 6 months before first injection\n* Oral corticotherapy ≥ 5mg\u002Fday (in Prednisone equivalent) in the last 3 months before first injection\n* OA treatments based on curcuma extract (e.g. FLEXOFYTOL) in the last 3 months before first injection\n* Change in the dosage of SYSAD i.e. chondroitin, glucosamine, diacerein or avocado-soy unsaponifiables in the last 3 months before first injection\n* Paracetamol and oral NSAIDs before inclusion and follow-up visits (washout period depending on the half-life of the drug, Appendix 4).\n* Osteoporosis-related treatments based on strontium ranelate, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months before first injection\n* An anticipated need for any forbidden OA treatments during the trial\n* Contraindications to HYMOVIS®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site.\n* Non-pharmacologic therapy (including physical therapy) for the lower extremities initiated in the month before first injection\n* Anticoagulant (coumarinic compound) and heparin\n\nRelated to associated diseases\n\n* Severe diseases (liver or renal failure, lung\u002Fheart disease, tumor, HIV….)\n* Allergy or contra-indication to hyaluronan\n* Severe alteration of mobility enabling functional evaluation\n* High risk of hemorrhage and risk of infection at the site of injection\n* Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee\n\nRelated to patients\n\n* Participation to a therapeutic clinical trial in the last 3 months before first injection\n* Under guardianship or judicial protection\n* Pregnancy, breastfeeding, planned conception, premenopausal women without contraception, tubal ligation or hysterectomy\n\nRelated to MRI counter-indication\n\n* Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump\n* Patient with a ferromagnetic splinter in the body, or having wire sutures\n* Serious mobility problem (Parkinson, tremors),\n* Claustrophobia","ALL","40 Years","80 Years",{"count":110,"type":111},50,"ACTUAL","INTERVENTIONAL",[114],"NA","This pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of patients suffering of knee osteoarthritis as revealed by using scientifically sound, objective measurements of biological and MRI-based imaging markers.",[117],"Knee Osteoarthritis",[119,120,121,122,123],"Hyaluronic acid","MRI","Biomarkers","Cartilage","pain","COMPLETED","2020-03-04",{"date":127,"type":111},"2020-03-06",{"date":129,"type":111},"2015-04-01",{"date":131,"type":111},"2017-06-06",{"name":5,"class":6},8]