[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100299028":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":165,"collaborators":168,"id":180,"slug":181,"hasResults":182,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":182,"sex":188,"minAge":189,"maxAge":26,"enrollmentInfo":190,"targetDuration":26,"studyType":193,"phases":194,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},{"fullName":5,"class":6},"Central Finland Hospital District","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ORIF (open reduction-internal fixation)","ACTIVE_COMPARATOR","Osteosynthesis with locking plate(s) will be performed using medial and\u002For lateral incision, according to morphology of the fracture. Additional osteosynthesis material will be used when necessary. The articular surface will be reduced and bone transplantation or bone substitute used if required.\n\nPostoperatively, touch-down weight bearing will be allowed for 6 weeks, followed by 2 weeks of half-weight-bearing period. A walker or wheelchair will be used when necessary.",[13],"Procedure: Locking plate",{"label":15,"type":16,"description":17,"interventionNames":18},"TKR (total knee replacement)","EXPERIMENTAL","Arthroplasty of the knee will be performed within two weeks after the fracture. Medial parapatellar approach will be used. The minimal possible constraint of the prosthesis (cruciate retaining, posterior cruciate sacrificing or semi-constrained) will be used. A possible insufficient bone stock may be rebuilt with augments. Hinged prosthesis will be used only if stability of the medial collateral ligament is insufficient. A cemented or uncemented tibial stem extender (minimum length 50mm) will be used in all cases. Additional osteosynthesis will be used when necessary. Postoperatively, the patients will be allowed full weight bearing as tolerated.",[19],"Procedure: TKR",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Locking plate","Osteosynthesis",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"TKR","Total knee arthroplasty",[15],[32],{"name":33,"affiliation":34,"role":35},"Juha Paloneva, MD, PhD","Central Finland Hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+358 14 2693119","juha.paloneva@ksshp.fi",[42,70,86,100,114,128,141,151],{"facility":34,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Jyväskylä","40620","Finland","FI",{"type":49,"coordinates":50},"Point",[51,52],25.72088,62.24147,{"lat":52,"lon":51},[55,56,58,61,63,64,66,68],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":26},{"name":57,"role":38,"phone":26,"phoneExt":26,"email":26},"Valtteri Tapper, MD",{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Alar Toom, MD, PhD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":26,"phoneExt":26,"email":26},"Valtteri Tapper, MD, PhD",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":65,"role":60,"phone":26,"phoneExt":26,"email":26},"Heikki Nurmi, MD, PhD",{"name":67,"role":60,"phone":26,"phoneExt":26,"email":26},"Maija Pesola, MD, PhD",{"name":69,"role":60,"phone":26,"phoneExt":26,"email":26},"Konsta Pamilo, MD, PhD",{"facility":71,"status":72,"city":73,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Kuopio University Hospital","NOT_YET_RECRUITING","Kuopio",{"type":49,"coordinates":75},[76,77],27.67703,62.89238,{"lat":77,"lon":76},[80,82,84],{"name":81,"role":38,"phone":26,"phoneExt":26,"email":26},"Jussi Jalkanen, MD",{"name":83,"role":35,"phone":26,"phoneExt":26,"email":26},"Jussi Jalkanen, MD, PhD",{"name":85,"role":60,"phone":26,"phoneExt":26,"email":26},"Tommi Kääriäinen, MD, PhD",{"facility":87,"status":72,"city":88,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Päijät-Häme Central Hospital","Lahti",{"type":49,"coordinates":90},[91,92],25.66151,60.98267,{"lat":92,"lon":91},[95,97,98],{"name":96,"role":38,"phone":26,"phoneExt":26,"email":26},"Jussi Haapala, MD, PhD",{"name":96,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":99,"role":60,"phone":26,"phoneExt":26,"email":26},"Sami Nurmi, MD",{"facility":101,"status":72,"city":102,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Oulu University Hospital","Oulu",{"type":49,"coordinates":104},[105,106],25.46816,65.01236,{"lat":106,"lon":105},[109,111,112],{"name":110,"role":38,"phone":26,"phoneExt":26,"email":26},"Tuukka Niinimäki, MD, PhD",{"name":110,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":113,"role":60,"phone":26,"phoneExt":26,"email":26},"Tero Kortekangas, MD, PhD",{"facility":115,"status":72,"city":116,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Seinäjoki Central Hospital","Seinäjoki",{"type":49,"coordinates":118},[119,120],22.82822,62.79446,{"lat":120,"lon":119},[123,125,126],{"name":124,"role":38,"phone":26,"phoneExt":26,"email":26},"Janne Jousmäki, MD, PhD",{"name":124,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":127,"role":60,"phone":26,"phoneExt":26,"email":26},"Ville Sumuvuori, MD, PhD",{"facility":129,"status":72,"city":130,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Coxa Joint Replacement Hospital","Tampere",{"type":49,"coordinates":132},[133,134],23.78712,61.49911,{"lat":134,"lon":133},[137,139],{"name":138,"role":38,"phone":26,"phoneExt":26,"email":26},"Jyrki Nieminen, MD",{"name":140,"role":35,"phone":26,"phoneExt":26,"email":26},"Jyrki Nieminen, MD, PhD",{"facility":142,"status":72,"city":130,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"Tampere University Hospital",{"type":49,"coordinates":144},[133,134],{"lat":134,"lon":133},[147,149],{"name":148,"role":38,"phone":26,"phoneExt":26,"email":26},"Minna Laitinen, MD, PhD",{"name":150,"role":35,"phone":26,"phoneExt":26,"email":26},"Ilari Pajamäki, MD",{"facility":152,"status":72,"city":153,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Turku University Hospital","Turku",{"type":49,"coordinates":155},[156,157],22.26869,60.45148,{"lat":157,"lon":156},[160,162,163],{"name":161,"role":38,"phone":26,"phoneExt":26,"email":26},"Niko Strandberg, MD, PhD",{"name":161,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":164,"role":60,"phone":26,"phoneExt":26,"email":26},"Mika Junnila, MD, PhD",{"type":35,"investigatorFullName":166,"investigatorTitle":167,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Juha Paloneva","Department head, adjunct professor",[169,170,172,173,175,176,178],{"name":142,"class":6},{"name":171,"class":6},"Coxa, Hospital for Joint Replacement",{"name":101,"class":6},{"name":152,"class":174},"OTHER_GOV",{"name":71,"class":6},{"name":177,"class":6},"Seinajoki Central Hospital",{"name":179,"class":6},"Paijat-Hame Hospital District","100299028","prosthesis-versus-osteosynthesis-in-proximal-tibia-fractures-100299028",false,"NCT03172715","Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures","Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial","POSITIF","Inclusion Criteria:\n\n* Acute intra-articular proximal tibia fracture with impression of the joint cartilage (Schatzker grades II to VI)\n* Impression of tibial plateau min 2 mm\n* Intact patellar tendon\n* The patient accepts both treatment options (osteosynthesis and arthroplasty)\n\nExclusion Criteria:\n\n* Not voluntary\n* Previous arthroplasty of the knee\n* Previous fracture affecting the knee joint\n* Inability to co-operate\n* Not independent (institutionalized living before fracture)\n* Severe osteoarthritis (Kellgren-Lawrence grade 4)\n* Open fracture (Gustilo grade 2 or over)\n* Progressive metastatic malign disease\n* Multiple fractures requiring operative treatment\n* Severe soft tissue injury around the knee (Tscherne classification grade 3)\n* Avulsion fracture of the patellar tendon or concomitant patellar tendon tear\n* Inability to walk before fracture\n* Severe medical comorbidities\n* Body Mass Index over 40\n* Unacceptably high risk of surgery due to severe medical comorbidities\n* Significant arterial or nerve trauma\n* Severe substance abuse","ALL","65 Years",{"count":191,"type":192},98,"ESTIMATED","INTERVENTIONAL",[195],"NA","The aim of this study is to compare knee function and pain one year after treatment of intra-articular proximal tibia fracture using either osteosynthesis with a locking plate (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.",[198],"Tibial Fractures",[200,201,202,203],"Open reduction internal fixation","Arthroplasty","Surgery","Randomized controlled trial","2024-08-21",{"date":206,"type":207},"2024-08-22","ACTUAL",{"date":209,"type":207},"2018-01-09",{"date":211,"type":192},"2029-06",{"name":5,"class":6},8]