[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558801":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":19,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":10,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":10,"overallStatus":22,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"BONESUPPORT AB","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CERAMENT G",null,"Subjects receiving CERAMENT G as part of the surgical treatment of Osteomyelitis",[13],"Device: CERAMENT G",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","CERAMENT G is intended for use as a bone void filler as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing.",[9],[20],{"facility":21,"status":22,"city":23,"state":10,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS","RECRUITING","Oxford","OX37HE","United Kingdom","UK",{"type":28,"coordinates":29},"Point",[30,31],-1.25596,51.75222,{"lat":31,"lon":30},[34,39],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Jamie Ferguson, MD","CONTACT","+447482491449","jamie.ferguson@ouh.nhs.uk",{"name":35,"role":40,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":54,"type":55},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.",[59],"Osteomyelitis","2026-04-28",{"date":62,"type":63},"2026-05-04","ACTUAL",{"date":65,"type":63},"2025-06-02",{"date":67,"type":55},"2032-10",{"name":5,"class":6},1]