[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"compression-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:compression-fracture":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100544338","spine-bone-cements-outcomes---post-market-follow-up-100544338",false,"NCT06367582","Spine Bone Cements Outcomes - Post Market Follow-up","Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up","Inclusion Criteria:\n\n* Be 18 years or older\n* Be willing to sign an informed consent approved by Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study\n\n  o For prospective inclusion:\n* Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study\n\n  o For retrospective inclusion:\n* Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 and the date of the site initiation visit.\n* Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).\n\nExclusion Criteria:\n\nPatients presenting one of the following conditions will not be included (contraindications per IFU):\n\n* Procedures other than those stated in the INDICATIONS section\n* Coagulation disorders, or severe cardiopulmonary disease\n* Unstable vertebral fractures\n* Compromise of the vertebral body or of the pedicle walls\n* Hypersensitivity or allergy to one of the constituents of the product\n* Patient clearly improving on more conservative treatment\n* Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture\n* Paediatric patients and pregnant or breast-feeding women.","ALL","18 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.\n\nTEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a \"real-life\" setting.\n\nThe study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.",[24,25,26],"Vertebral Fracture","Compression Fracture","Osteoporotic Fractures","RECRUITING","2025-09-02",{"date":30,"type":31},"2025-09-09","ACTUAL",{"date":33,"type":31},"2019-09-04",{"date":35,"type":20},"2039-09-30",{"name":37,"class":38},"Teknimed","INDUSTRY",12,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100545234","development-and-validation-of-a-postoperative-re-fracture-risk-model-for-osteoporotic-spinal-fractures-100545234","NCT06379243","Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures","Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study","Inclusion Criteria:\n\n* Patients diagnosed with osteoporotic vertebral fractures of the thoracic and lumbar level with reference to the 2022 edition of the Osteoporotic Fractures Guidelines (2022 edition);\n* The presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae is clearly defined by MR examination, and the responsible vertebrae is treated with PVP \u002F PKP;\n* Number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures).\n\nExclusion Criteria:\n\n* History of severe scoliosis, vertebroplasty, or internal spinal fixation;\n* Presence of spinal infection and malignant neoplastic disease;\n* Presence of mental disease, cognitive impairment, or critical illness (e.g., severe cardiac or cerebrovascular disease).","50 Years","90 Years",{"count":50,"type":20},560,"INTERVENTIONAL",[53],"NA","In this project, IDEAL-IQ technology and PDFF and R2\\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP \u002F PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP \u002F PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP\u002F PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2\\*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).",[56,57,25,58],"Osteoporosis Fracture","Osteoporosis Vertebral","Perform PVP \u002F PKP Treatment",[60,61,62],"osteoporosis","spinal vertebral fractures","PVP \u002F PKP treatment","2024-04-21",{"date":65,"type":31},"2024-04-23",{"date":67,"type":31},"2023-12-01",{"date":69,"type":20},"2027-12-31",{"name":71,"class":72},"The Seventh Affiliated Hospital of Sun Yat-sen University","OTHER",1]