[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485968":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":49,"collaborators":7,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":7,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":7,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"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",[20,38],{"facility":21,"status":22,"city":23,"state":7,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"GZA Ziekenhuizen - campus Sint-Augustinus","RECRUITING","Antwerp","2610","Belgium","BE",{"type":28,"coordinates":29},"Point",[30,31],4.40026,51.22047,{"lat":31,"lon":30},[34],{"name":35,"role":16,"phone":36,"phoneExt":7,"email":37},"Bart Stuyts, Dr.","+32 3 443 48 11","bart.stuyts@emmaus.be",{"facility":39,"status":22,"city":40,"state":7,"zip":41,"country":25,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"AZ Voorkempen","Malle","2390",{"type":28,"coordinates":43},[44,45],4.7109,51.29917,{"lat":45,"lon":44},[48],{"name":35,"role":16,"phone":36,"phoneExt":7,"email":37},{"type":50,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100485968","a-post-market-observational-origin-cr-clinical-study-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":61,"type":62},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.",[66],"Total Knee Replacement",[68,69,70],"ORIGIN","TKA","Prosthesis","2024-10-03",{"date":73,"type":74},"2024-10-08","ACTUAL",{"date":76,"type":74},"2024-07-10",{"date":78,"type":62},"2028-02",{"name":5,"class":6},2]