[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bone-defect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bone-defect":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100609013","flexioss---efficacy-safety-and-long-term-radiological-and-clinical-outcomes-during-comprehensive-care-continuum-of-implanted-biocomposite-for-bone-regeneration-100609013",false,"NCT07209033","FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.","A Prospective, Randomized, Double-blinded, Multi-center, Non-inferiority Study Evaluating the Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration FlexiOss® Compared to the Current Standard of Care in Patients With Primary Acute Trauma Bone Defects.","FlexiOssOT","Inclusion Criteria:\n\n1. Age between 18 and 75 years.\n2. Subject signed informed consent form and is willing to participate in the follow-up visits.\n3. Subject with an existing acute primary bone defect in one of the following groups:\n\n   1. Long bones of the lower extremity (including articular tibia plateau acute fracture).\n   2. Bones of the foot (including articular calcaneus acute fracture).\n4. Subject scheduled for orthopedic procedure with bone substitute material.\n\nExclusion Criteria:\n\n1. Subject with alcohol dependence syndrome or any history of substance abuse within the past year.\n2. Pregnancy or breastfeeding.\n3. Subject participates in another clinical trial.\n4. Unstable mental condition or psychiatric concomitant disease.\n5. Diagnosed severe degenerative, metabolic bone disease or any condition that in opinion of the Investigator could adversely affect bone healing and regeneration.\n6. Subject with known allergies or hypersensitivity to any components of the FlexiOss® biocomposite material\n7. Subject with active cancer disease and\u002For during related oncological treatment.\n8. Contraindications for computed tomography angiography according to the site Standard of Care include, but are not limited to, allergic reactions to contrast agents and impaired renal function.\n9. Subject with severe comorbidities that could interfere with the study outcomes or pose a risk during surgery and rehabilitation.\n10. Any other condition precluding implantation of FlexiOss®.","ALL","18 Years","75 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","The aim of this clinical study is to evaluate the efficacy, safety and long-term (radiological and clinical) outcomes during comprehensive care continuum of implanted biocomposite for bone regeneration FlexiOss® compared to the current standard of care in patients with primary acute trauma bone defects.\n\nThe efficacy, safety and long-term (radiological and clinical) evaluation will be assessed during follow up visits at 2, 6 weeks, 3, 6, 12 and 24 months.",[28],"Bone Defect",[28,30,31,32,33],"Bone Trauma","Bone Injury","Biocomposite","Bone Regeneration","RECRUITING","2026-02-10",{"date":37,"type":38},"2026-02-12","ACTUAL",{"date":40,"type":38},"2025-05-29",{"date":42,"type":22},"2028-06",{"name":44,"class":45},"Medical Inventi S.A.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100598033","bone-reconstruction-with-autologous-bone-marrow-mesenchymal-stem-cells-in-vitro-to-repair-long-tubular-bone-defects-100598033","NCT07066228","Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Long Tubular Bone Defects","Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Long Tubular Bone Defects of Limbs","Inclusion Criteria:\n\n1. Age: 18-55 years old, gender unrestricted;\n2. Defective nonunion with bone loss exceeding 30% of the bone cross-section and a length of 2-3 cm;\n3. Solitary bone cysts involving more than 50% of the bone cross-section.\n\nExclusion Criteria:\n\n1. Combined with local tumors, tuberculosis, infections or other bone-healing affecting lesions;\n2. Systemic diseases affecting bone healing such as osteofibrous dysplasia, osteogenesis imperfecta, bone dystrophic diseases, and metabolic bone disorders;\n3. Moderate-to-severe osteoporosis (BMD: T-score \\\u003C -2.5);\n4. Severe systemic conditions including systemic malnutrition, systemic infectious diseases, severe cardiopulmonary diseases, coagulation disorders, and major organ failure;\n5. Complicated with severe brain trauma;\n6. Heavy smoking, drug abuse, alcoholism, or other harmful addictions;\n7. Psychiatric disorders or patients with menopausal symptoms;\n8. Concurrent participation in other studies or recent completion (within 4 weeks) of other clinical trials;\n9. Pregnancy, lactation, or planned pregnancy within one year after initial enrollment;\n10. Psychological conditions impairing treatment compliance;\n11. Congenital malformations of vital organs or other systems;\n12. Nonunion caused by malignant tumor resection;\n13. Refusal to accept tissue-engineered bone repair protocol.","55 Years",{"count":55,"type":22},30,[25],"Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro to explore the effect of this tissue engineered bone in the clinical repair of long tubular bone defects in limbs.",[59,60,28,61],"Defective Composite Restorations","Bone Cysts","Bone Nonunion",[63,64,65],"autologous bone marrow mesenchymal stem cells","DBM","long tubular bone defects of limbs","2025-12-28",{"date":68,"type":38},"2026-01-02",{"date":70,"type":38},"2025-08-07",{"date":72,"type":22},"2028-12",{"name":74,"class":75},"The First Affiliated Hospital of Xinxiang Medical College","OTHER",1]