[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457603":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":65,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Lindenhofgruppe AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group 5-5.4 cc ViviGen®","ACTIVE_COMPARATOR","Biological: 5-5.4 cc ViviGen® The ALIF or XLIF fusion patients assigned to this group will receive 5-5.4 cc ViviGen®",[13],"Other: ViviGen®",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group 4-6mg rhBMP-2","Biological: 4-6mg rhBMP-2 The ALIF or XLIF fusion patients assigned to this group will receive 4-6mg rhBMP-2",[18],"Other: rhBMP-2",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"OTHER","ViviGen®","It will investigate the radiological and clinical outcome of ALIF procedure L5\u002FS1 and XLIF L4\u002FL5 procedure using two arms\u002F treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®\u002F rhBMP-2 ratio will be 1:1.",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":29},"rhBMP-2",[15],[30],"InductOS",[32],{"name":33,"affiliation":34,"role":35},"Diel Peter, Dr. med.","Orthopädie Sonnenhof, Bern","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Diel Peter, Dr. med","CONTACT","+41 31 358 17 90","peter.diel@sonnenhof.ch",{"name":43,"role":39,"phone":44,"phoneExt":25,"email":45},"Sabine Berger","+41 79 328 50 24","sabine.berger@lindenhofgruppe.ch",[47],{"facility":48,"status":49,"city":50,"state":25,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Orthopädie Sonnenhof","RECRUITING","Bern","3006","Switzerland","CH",{"type":55,"coordinates":56},"Point",[57,58],7.44744,46.94809,{"lat":58,"lon":57},[61,63],{"name":62,"role":39,"phone":40,"phoneExt":25,"email":41},"Peter Diel, Dr.med.",{"name":43,"role":39,"phone":64,"phoneExt":25,"email":45},"+41793285024",{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100457603","comparison-of-radiographic-fusion-rate-and-clinical-outcome-of-alif-and-xlif-performed-with-either-recombinant-human-bone-morphogenetic-protein-2-or-vivigen-100457603",false,"NCT05238740","Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®","Comparison of Radiographic Fusion Rate and Clinical Outcome of Anterior Lumbar and Extreme Lateral Interbody Fusion Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomised Assessor Blind, Monocentric Trial","Inclusion criteria:\n\nPatients who have an indication for a monosegmental ALIF procedure on the L5\u002FS1 segment or a monosegmental XLIF procedure on L4\u002F5 (both ALIF and XLIF procedure with or without an additional pedicular stabilisation), e.g., treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and\u002For leg pain\n\n* Patients must be 18 - 70 years of age\n* Patients must have understood and signed the study information and the informed consent form\n* Patients are willing and able to complete scheduled follow-up evaluations \u002F questionnaires as described in the Informed Consent\n\nExclusion criteria:\n\n* Patients under 18 years and over 70 years of age\n* Patients with tumour \u002F spine trauma \u002F known bone disease \u002F Parkinson's disease and similar CNS disorders \u002F diseases or injuries of the peripheral nerves\n* Other procedures or segment than mentioned in the inclusion citeriaAdditional planed spine surgeries after index surgery\n* Current smoking\n* Pregnant or breastfeeding patients (or patient planning a pregnancy within one year after surgery)\n* Insufficient language skills in German\n* Inability to give informed consent\n* Refusal to participate in the study, unsigned study consent\n* Participation in another interventional study within the 30 days preceding and during the present study","ALL","18 Years","70 Years",{"count":78,"type":79},168,"ESTIMATED","INTERVENTIONAL",[82],"NA","The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5\u002FS1 and in monosegmental XLIF procedure L4\u002F5",[85,86,87],"Spondylosis","Spondylolisthesis","Degenerative Disc Disease",[89,90,91,92,85,86,87,93],"ViviGen","Radiographic fusion rate","Anterior lumbar interbody fusion","Recombinant human bone morphogenetic protein-2","Extreme lateral interbody fusion","2025-06-04",{"date":96,"type":97},"2025-06-08","ACTUAL",{"date":99,"type":97},"2022-10-27",{"date":101,"type":79},"2027-12",{"name":5,"class":6},1]