[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BONESUPPORT AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100558801","cerament-g-as-part-of-the-surgical-treatment-of-osteomyelitis-in-a-single-stage-procedure-100558801",false,"NCT06555848","CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure","A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure","CERTITUDE","Inclusion Criteria:\n\nSubjects meeting the following inclusion criteria are to be included in the analysis:\n\n1. Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.\n2. Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:\n\n   1. the presence of a sinus\n   2. the presence of an abscess or intra-operative pus\n   3. the presence of positive supportive histology\n   4. two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., Staph aureus) with similar antimicrobial sensitivity) Notes: In cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. Infected non-unions will be included only if the bone loss is \\\u003C 1cm after debridement and excision of bone has been performed.\n\nExclusion Criteria:\n\nThe subject will be excluded from the study if:\n\n1. Skeletal immaturity, defined as pre-operative\u002F screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)\n2. Those unable to give informed consent for inclusion in the trial, or those not willing to be included\n3. A known allergy or reaction to gentamicin or calcium sulfate\n4. Treatment with a combination of different antibiotic-eluting bone graft substitutes\n5. They have a segmental bone defect \\> 1cm\n6. Infection of the spine","ALL","18 Years",{"count":20,"type":21},128,"ESTIMATED","OBSERVATIONAL","The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.",[25],"Osteomyelitis","RECRUITING","2026-04-28",{"date":29,"type":30},"2026-05-04","ACTUAL",{"date":32,"type":30},"2025-06-02",{"date":34,"type":21},"2032-10",{"name":36,"class":37},"BONESUPPORT AB","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":45,"targetDuration":47,"studyType":22,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},"100381311","cerament-bone-void-filler-device-registry-100381311","NCT04244942","CERAMENT™| Bone Void Filler Device Registry","Inclusion Criteria:\n\n* 18 years and over (on the day of surgery)\n* Receive CERAMENT BVF as a component of their treatment at a participating, contracted center or healthcare provider, in accordance with the IFU for the implanted product\n* In receipt of patient information leaflet and have signed appropriately designed informed consent\n\nExclusion Criteria:\n\n* Any exclusion criteria as per IFU for CERAMENT BVF\n* Any off-label use",{"count":46,"type":21},300,"18 Months","A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.",[50],"Orthopedic Disorder","2025-09-24",{"date":53,"type":30},"2025-09-29",{"date":55,"type":30},"2020-03-30",{"date":57,"type":21},"2028-03-30",{"name":36,"class":37},13,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":68,"studyType":22,"phases":4,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":5},"100516891","cerament-g-device-registry-100516891","NCT06010433","CERAMENT G Device Registry","Inclusion Criteria:\n\n* 18 years and over (on the day of surgery)\n* receive CERAMENT\\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product\n* In receipt of patient information leaflet and have signed appropriately designed informed consent form.\n\nExclusion Criteria:\n\n* Any exclusion criteria as per IFU for CERAMENT\\|G\n* Any off-label use",{"count":67,"type":21},100,"12 Months","This is an Observational Device Registry Study of CERAMENT\\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.",[71,72,73],"Chronic Osteomyelitis","Fracture Related Infection","Diabetic Foot Osteomyelitis","2025-09-23",{"date":76,"type":30},"2025-09-26",{"date":78,"type":30},"2023-08-17",{"date":80,"type":21},"2028-09-22",{"name":36,"class":37},""]