[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Teknimed\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,66,98],{"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":25,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100544857","bone-substitutes-outcomes---post-market-follow-up-100544857",false,"NCT06374342","Bone Substitutes Outcomes - Post Market Follow-up","Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - 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 IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France) and\n\n  o For prospective inclusion:\n* Be considered for a surgery where bone filling with one of the TEKNIMED bone substitutes comprised in this study is needed and intended to be used according to the IFU.\n\n  o For retrospective inclusion:\n* Have undergone a surgery with a TEKNIMED bone substitute used according to the IFU, between the 1st January 2015 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 (France) or be willing to sign an informed consent (where applicable) during the first follow-up visit following the site initiation.\n\nExclusion Criteria:\n\nPatients presenting one of the following conditions will not be included:\n\n* Under trusteeship or guardianship\n* Pregnancy or breast-feeding women\n\nAccording to contraindications per IFU:\n\n* Procedures other than those stated in the INDICATIONS section\n* Patients susceptible to allergic reactions to the product components.\n\nCERAFORM®, TRIHA+®:\n\n\\- Treatment of large bone defects which could impact the stability of bone structure without implementing a mechanical stabilisation system (such as plate(s), screw(s), nail(s), cage(s))\n\nNANOGEL®:\n\n* Use in vertebroplasty procedures\n* Subcutaneous use","ALL","18 Years",{"count":19,"type":20},425,"ESTIMATED","OBSERVATIONAL","A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.\n\nTEKNIMED bone substitutes are legacy products, some marketed for more than 20 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],"Bone Resorption",[26,27,28,29,30,31],"Bone substitutes","Gel","Hydroxyapatite","Tricalcium phosphate","Calcium phosphate","Ceramics","RECRUITING","2025-09-02",{"date":35,"type":36},"2025-09-09","ACTUAL",{"date":38,"type":36},"2021-09-16",{"date":40,"type":20},"2032-09-30",{"name":42,"class":43},"Teknimed","INDUSTRY",6,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100544338","spine-bone-cements-outcomes---post-market-follow-up-100544338","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.",{"count":53,"type":20},500,"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.",[56,57,58],"Vertebral Fracture","Compression Fracture","Osteoporotic Fractures",{"date":35,"type":36},{"date":61,"type":36},"2019-09-04",{"date":63,"type":20},"2039-09-30",{"name":42,"class":43},12,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100557039","sport-surgery-products-outcomes---a-post-market-follow-up-100557039","NCT06532929","Sport Surgery Products Outcomes - A Post-market Follow-up","Safety and Clinical Performance Assessment of Sport Surgery Products - 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 IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France)\n\nFor prospective inclusion:\n\n\\- Be considered for a surgery with one of the TEKNIMED sports surgery product comprised in this study.\n\nFor retrospective inclusion:\n\n* Have undergone a surgery with a TEKNIMED sports surgery product between the 1st 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 (France) or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).\n\nExclusion Criteria:\n\n* Patients presenting one of the following conditions will not be included: under trusteeship or guardianship, pregnancy\n* Anyone of the contraindications mentioned in the respective IFU of each device under study",{"count":74,"type":20},390,"Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products. TEKNIMED has developed several devices currently used in orthopaedic surgery. With the increasing use of these procedures, there is a need for real-life long-term safety and efficacy data on these products.\n\nThe study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.",[77],"Sport Surgery",[79,80,81,82,83,84,85,86,87,88],"knee","shoulder","sport","surgery","suture","ligamentoplasty","anchors","screw","resorbable","pins","2025-03-24",{"date":91,"type":36},"2025-03-27",{"date":93,"type":36},"2019-11-01",{"date":95,"type":20},"2036-11",{"name":42,"class":43},10,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":97},"100543336","arthroplasty-cements-outcomes---a-post-market-follow-up-100543336","NCT06354543","Arthroplasty Cements Outcomes - A Post-market Follow-up","Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - 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 Institutional Review Board (IRB) or European Commission (EC) (when applicable) or not oppose to the use of their clinical data in the study\n* For prospective inclusion: be considered for an arthroplasty procedure with one of the TEKNIMED orthopaedic cement and\u002For cement restrictor comprised in this study (primary or revision surgery).\n* For retrospective inclusion: have undergone a primary or revision arthroplasty procedure with a TEKNIMED orthopaedic cement and\u002For cement restrictor between the 1st January 2016 and the date of the site initiation visit (SIV).\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 (where applicable).\n\nExclusion Criteria:\n\n* Patient under trusteeship or guardianship,\n* Women who are pregnant\n* Patient unable to follow the protocol\n* Patient whose vital prognosis is unfavorable (according to investigator's opinion)",{"count":106,"type":20},1050,"A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.\n\nTeknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 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, ambispective observational study. Patients will be followed as per local standard medical care of the site.",[109],"Arthroplasty",[111,112,113,79,114,80,115],"cement","prosthesis","arthroplasty","hip","joint",{"date":117,"type":36},"2025-03-25",{"date":119,"type":36},"2020-12-16",{"date":121,"type":20},"2045-12",{"name":42,"class":43},""]