[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575662":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":64,"collaborators":18,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":18,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Maria-Josef-Hospital Greven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"operated group (partial meniscal replacement)","ACTIVE_COMPARATOR","Patients, who decide to get operated will be in the experimental group, Spongioflex® will be the investigational product",[13],"Procedure: partial meniscal replacement with Spongioflex®",{"label":15,"type":16,"description":17,"interventionNames":18},"non-operated patients","NO_INTERVENTION","Patients who do not decide to be operated at this stage, but want to be closely monitored to eventually join the operated group later.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","partial meniscal replacement with Spongioflex®","for any surgical procedure, the patient receives an antibiotic shot NIMP) just before surgery. The patient will be arthroscopically treated via the arthroscopic portal with implantation of a demineralized bone block (IMP: Spongioflex ®, appropriate size (DIZG gGmbH, Berlin, Germany)) as a partial meniscus substitute. The block will be adapted to the defect size and secured with 2-4 inside-out sutures (Etibond 0, Ethicon, Somerville, NJ). No dosing, the IMP has no systemic effect. The surgery (Intervention) will last between 60-90 minutes. The hospital stay is between 2-3 days after surgery. Follow-up visits: at the end of the hospital stay, after 6 weeks, after 6, 12 and 24 months and after 5 years for the operated group.",[9],[26],{"name":27,"affiliation":28,"role":29},"Clemens Kösters, PD, Dr. med","Maria-Josef-Hospital Greven GmbH","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Clemens Kösters, PD, Dr. med.","CONTACT","+49-2571-502-12001","Clemens.Koesters@mjh-greven.de",{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},"Daniel A den Toom, Dr. med","daniel.toom@mhj-greven.de",[40],{"facility":28,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Greven","North Rhine-Westphalia","48268","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],7.59396,52.09364,{"lat":51,"lon":50},[54,56,58,60,62],{"name":55,"role":33,"phone":34,"phoneExt":18,"email":35},"Clemens Kösters, PD. Dr. med.",{"name":37,"role":33,"phone":34,"phoneExt":18,"email":57},"daniel.toom@mjh-greven.de",{"name":59,"role":33,"phone":18,"phoneExt":18,"email":18},"Clemens Kösters, PD Dr. med.",{"name":61,"role":33,"phone":18,"phoneExt":18,"email":18},"Daniel A den Toom, Dr. med.",{"name":63,"role":33,"phone":18,"phoneExt":18,"email":18},"Malte L Rüter",{"type":65,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100575662","phase-4-partial-meniscal-replacement-with-spongioflex-100575662",false,"NCT06775197","Partial Meniscal Replacement with Spongioflex®","Sterile Allogeneic Spongioflex® Allograft As Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-initiated Trial","Inclusion Criteria:\n\n1. Patients (male and female) with:\n2. Partial loss of portions of the\n\n   * lateral meniscus and lateral joint line pain OR\n   * medial meniscus and medial joint line pain\n3. sufficient standing of the peripheral rim, so that the procedure can be performed\n4. Age: 18-60 years\n5. signed written informed consent to the study and to provide the scientific data in pseudonymized form\n\nExclusion Criteria:\n\n1. The presence of anterior cruciate ligament insufficiency which is not resolved by reconstruction of the anterior cruciate ligament within 16 weeks after partial meniscal implantation.\n2. Axial deviation (\\>2° varus or valgus)\n3. realignment osteotomy not performed within 12 weeks\n4. advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence \\[33\\])\n5. Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125°\n6. inflammatory arthritis or synovitis on the treated knee\n7. BMI greater than 30 kg\u002Fm²\n8. \\\u003C18 years, \\>60 years\n9. Chronic pain patients\n10. only for patients who will be operated:\n\n    1. with increased anaesthesiologic risk, e.g., with known or predicted difficult airway\n    2. with increased risk of bleeding\n    3. with increased risk of infection\n    4. with necrotic, infected, or poorly perfused host sides\n    5. history of allergic reactions\n    6. acute hypersensitivity reactions to the IMP or any of its excipients\n    7. pregnant woman","ALL","18 Years","60 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","The purpose of this investigator-initiated trial is to evaluate whether the novel graft can prevent\u002Freduce the disadvantages of the previously used replacement materials and shows better results than the group of patients, which were not operated. Since there is currently no alternative made of biological material to this product, this investigator-initiated trial is of great medical and economic importance. The otherwise following arthrosis or knee prosthesis implantation (TKA ) could be prevented or at least postponed. Initial clinical results are promising.\n\nAn important and sensitive parameter for assessing the postoperative function of the meniscus is the MRI image. Genovese et al. 2007 were able to show in a categorization\u002Fclassification which magnetic resonance image can be expected in the case of successful incorporation. Several studies have shown that the known clinical knee scores (Lysholm, IKDC, KOOS, VAS pain) improve significantly after successful ingrowth of the meniscus implant.",[84,85,86,87,88,89],"Partial Meniscal Loss","Lateral Meniscus Partial Loss","Medial Meniscal Partial Loss","Meniscus Lesion","Meniscal Injuries","Meniscal Tear",[91,92,93,94,95,96,97,98,99],"partial meniscal loss","Allograft","Spongioflex®","IKDC","KOOS","return to sport","Outerbridge score","extrusion","VAS pain score","2025-01-09",{"date":102,"type":103},"2025-01-15","ACTUAL",{"date":105,"type":103},"2024-11-05",{"date":107,"type":78},"2031-11-05",{"name":5,"class":6},1]