[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545017":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":54,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Privatpraxis für Knie- und Schulterchirurgie","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Spongioflex®","EXPERIMENTAL","As for any surgical procedure, the patient receives an antibiotic shot non-interventional medicinal product (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.",[13],"Procedure: Spongioflex®",{"label":15,"type":6,"description":16,"interventionNames":17},"non-operated","no surgical treatment, no antibiotic shot, no visit at the end of the hospital stay, and no visit after 6 weeks. Follow-up visits after 6, 12 and 24 months and after 5 years.",[18],"Other: non-operated",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","partial meniscal replacment during surgery, follow-up visits at the end of hospital stay and after 6 weeks, MRI evaluation and questionnaires after 6, 12, 24 and 60 months.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"no surgery, MRI evaluation and questionnaires follow-up after 6, 12, 24 and 60 months",[15],[29],{"name":30,"affiliation":5,"role":31},"Sven Behrendt, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","+49231 8626064","praxis@dr-sven-behrendt.de",[38],{"facility":39,"status":40,"city":41,"state":24,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Privatpraxis für Knie und Schulterchirurgie","RECRUITING","Dortmund","44137","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],7.466,51.51494,{"lat":49,"lon":48},[52,53],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Sven Behrendt","principal investigator","100545017","sterile-allogeneic-spongioflex-allograft-as-partial-meniscal-replacement-after-incomplete-meniscal-loss-100545017",false,"NCT06376422","Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss","Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-initiated Low Interventional 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":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female\u002Fmale) with partial meniscal loss. The main questions it aims to answer are:\n\n* Can partial meniscal replacement improve knee function?\n* Can partial meniscal replacement prevent\u002Fpostpone total meniscal replacement\u002Fknee prothesis? Researchers will compare the results of the operated group with patients not willing to be operated but with partial meniscal loss to see if the operation improves knee function.\n\nParticipants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery.",[76],"Meniscus Lesion",[78,79,9,80,81,82,83,84,85],"meniscus deficiency","partial meniscus replacement","Allograft","International Knee Documentation Committee (IKDC) Score","Knee Injury and Osteoarthritis Outcome Score (KOOS)","Visuelle Analogskala (VAS) Score","Extrusion","magnetic resonance imaging (MRI)","2025-08-01",{"date":88,"type":89},"2025-08-06","ACTUAL",{"date":91,"type":89},"2024-04-30",{"date":93,"type":70},"2031-04-30",{"name":56,"class":6},1]