[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485968":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":48,"collaborators":7,"id":50,"slug":7,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":7,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":7,"studyType":61,"phases":7,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Symbios Orthopedie SA","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","ORIGIN® CR devices","It is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR devices.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Bojana Gannevat","CONTACT","+41 4242626","bojana.gannevat@symbios.ch",[20,37],{"facility":21,"status":22,"city":23,"state":7,"zip":24,"country":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"GZA Ziekenhuizen - campus Sint-Augustinus","RECRUITING","Antwerp","2610","Belgium",{"type":27,"coordinates":28},"Point",[29,30],4.40026,51.22047,{"lat":30,"lon":29},[33],{"name":34,"role":16,"phone":35,"phoneExt":7,"email":36},"Bart Stuyts, Dr.","+32 3 443 48 11","bart.stuyts@emmaus.be",{"facility":38,"status":22,"city":39,"state":7,"zip":40,"country":25,"cosmosGeoPoint":41,"geoPoint":45,"contacts":46},"AZ Voorkempen","Malle","2390",{"type":27,"coordinates":42},[43,44],4.7109,51.29917,{"lat":44,"lon":43},[47],{"name":34,"role":16,"phone":35,"phoneExt":7,"email":36},{"type":49,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100485968",false,"NCT05607966","A Post-market Observational ORIGIN® CR Clinical Study","Inclusion Criteria:\n\n* Male and female over 18 years of age\n* Each patient who is willing to give informed consent.\n* Clinically indicated for a total knee replacement\n* Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age\n* Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.\n\nExclusion Criteria:\n\n* Acute or chronic, local or systemic infection\n* Muscular, ligamental, neurological, psychological or vascular deficits\n* Bone destruction or poor bone quality likely to affect implant stability (requiring a femoral and\u002For a tibial stem and\u002For a thick insert)\n* Any concomitant condition likely to affect implant integration or function\n* Allergy or hypersensitivity to any of the materials used\n* For devices in CoCrMo (ISO 5832\u002F4): renal and hepatic impairment\n* Hip Knee Ankle (HKA) angle \\\u003C 165° or \\> 195°\n* Severe collateral ligaments deficiency (requiring a more constrained prosthesis)\n* Posterior cruciate ligament deficiency\n* Major anatomical deformities\n* Severe flexion contracture or severe recurvatum\n* Revision of a partial or total knee prosthesis\n* Non-extractible material (e.g. screws, plate, intramedullary nail, osteosynthesis material…) which can create a conflict with any component of the prosthesis\n* Distal and\u002For posterior and\u002For anterior femoral bone loss which exceeds the femoral component thickness\n* Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert)\n* Bone degradation requiring an anchoring stem for femoral component","ALL","18 Years","99 Years",{"count":59,"type":60},199,"ESTIMATED","OBSERVATIONAL","The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year post procedure.\n\nThe hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® CR.",[64],"Total Knee Replacement",[66,67,68],"ORIGIN","TKA","Prosthesis","2024-10-03",{"date":71,"type":72},"2024-10-08","ACTUAL",{"date":74,"type":72},"2024-07-10",{"date":76,"type":60},"2028-02",{"name":5,"class":6},2]