[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518219":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":45,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Clinique Paris-Bercy","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Subchondroplasty",null,"AccuFill Porous Bone Substitute Material (BSM) will be administrated to the patient during a subchondroplasty procedure (treatment visit).\n\nDuring the inclusion visit and the follow-up visits (Week 3, Week 6; Month 3, Month 6, Month 12, Month 24, Month 36, Month 48) the doctor will proceed the usual clinical exam and the patients will fulfil the validated questionnaires and scales to assess pain, functional impairments and subjective improvement.",[13],"Device: AccuFill® Porous Bone Substitute Material (BSM)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","AccuFill® Porous Bone Substitute Material (BSM)","The patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM).",[9],[9],[22],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},"Guy Mylle, Dr","CONTACT","01 44 01 01 02","guymylle@gmail.com",[28],{"facility":29,"status":10,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Clinique Paris Bercy","Charenton-le-Pont","94220","France","FR",{"type":35,"coordinates":36},"Point",[37,38],2.41217,48.82209,{"lat":38,"lon":37},[41],{"name":23,"role":42,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[46,49],{"name":47,"class":48},"CEISO","INDUSTRY",{"name":50,"class":51},"ClinServ","UNKNOWN","100518219","prospective-evaluation-of-subchondroplasty-in-advanced-knee-osteoarthritis-100518219",false,"NCT06027697","Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.","Inclusion Criteria:\n\n* Patient 18 years of age or older;\n* Patient with a Body Mass Index ≤35 (BMI=kg\u002Fm2);\n* Patient with Kellgren-Lawrence grade 3-4 Osteoarthritis, as reviewed on MRI and plain radiography;\n* Patient with knee bone marrow lesions confirmed by MRI result at least 3 months before the intervention;\n* Patients with degenerative knee pathology at the prosthetic stage (outdated medical treatments), with a frontal deformity of less than 12°, (and wishing to avoid or delay the prosthetic procedure as much as possible) \u002F goniometry);\n* Patient with unbearable mechanical pain with a walking perimeter limited at 500 m\n* Patient with non-surgical treatment failure (infiltration of Platelet Rich Plasma (PRP), corticoids, acid hyaluronic);\n* Patient who agrees to participate in the study and who signed the informed non-opposition form;\n* Patient physically and mentally willing and able, in the Investigator's opinion at the time of enrolment, to be compliant with the protocol including all follow-up visits, survey completion, weight- bearing restrictions, and post-operative rehabilitation;\n* Patient with social protection.\n\nExclusion Criteria:\n\n* Patient with a Body Mass Index \\> 35 (BMI=kg\u002Fm2);\n* Patient with inflammatory rheumatic pathologies;\n* Patient with frontal deformities (varus, valgus) of more than 12°;\n* Patient with degenerative pathologies at the operative stage but likely to benefit from a conservative intervention (osteotomy), except if the knee is centred;\n* Patient with stiff knees (more than 20° of flexum and\u002For less than 90° of flexion);\n* Patient with painful severe femoro-patellar osteoarthritis;\n* Patient with contraindications for Magnetic Resonance Imaging (MRI);\n* Patient with history of systemic diseases which could contribute to secondary arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease);\n* Patient with history of cognitive-behavioural disorders that could interact with assessment by self-questionnaire;\n* Patient with local or general infection or suspicion of infection;\n* Patient with severe coagulation disorders;\n* Patient with primary bone tumour in the knee area,\n* Patient with undercurrent serious pathology with life expectance \\\u003C 2 years;\n* Female patient of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;\n* Patient who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection;\n* Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study;\n* Patients who cannot read or write French","ALL","18 Years",{"count":61,"type":62},55,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the technique of subchondroplasty in patients with advanced knee osteoarthritis.\n\nThe main question it aims to answer is:\n\n• Does the subchondroplasty technique with the administration of AccuFill Porous Bone Substitute Material (BSM) is effective in the relief of mechanical pain in patient with knee osteoarthritis ?\n\nParticipants will go under a minimally invasive surgery procedure (subchondroplasty) and fulfil 3 validated questionnaires to assess pain, functional impairments and subjective improvement.\n\nThis study will be conducted for 4 years.",[66],"Knee Osteoarthritis",[68,9,69,70,71],"Knee osteoarthritis","Knee mechanical pain","AccuFill Porous Bone Substitute Material","Minimally invasive surgical procedure","NOT_YET_RECRUITING","2023-08-31",{"date":75,"type":76},"2023-09-07","ACTUAL",{"date":78,"type":62},"2023-12",{"date":80,"type":62},"2028-09",{"name":5,"class":6},1]