[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100368250":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":140,"collaborators":39,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":39,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":80,"whyStopped":39,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Ostfold Hospital Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Darrach","ACTIVE_COMPARATOR","Surgical procedure: resection of distal ulna",[13],"Procedure: Darrach",{"label":15,"type":10,"description":16,"interventionNames":17},"Prosthesis","Surgical procedure: ulnar head replacement",[18],"Procedure: Prosthesis",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Surgical treatment of painful DRU osteoarthritis with resection of distal ulna",[9],[25],"resection of ulnar head (Darrach procedure)",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Surgical treatment of painful DRU osteoarthritis with distal ulna replacement with Herbert implant",[15],[30],"Herbert disltal ulna implant",[32],{"name":33,"affiliation":5,"role":34},"Istvan Zoltan Rigo, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","+47 69860000",null,"istvan.zoltan.rigo@so-hf.no",{"name":42,"role":37,"phone":38,"phoneExt":39,"email":43},"Jan-Ragnar Haugstvedt, PhD","Jan-Ragnar.Haugstvedt@so-hf.no",[45,64,78,97,111,125],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Innlandet Hospital Trust","NOT_YET_RECRUITING","Lillehammer","Oppland","2629","Norway","NO",{"type":54,"coordinates":55},"Point",[56,57],10.46628,61.11514,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":39,"email":63},"Ole Anton Kragh Fosse, MD","915 06 200","ole.a.k.fosse@sykehuset-innlandet.no",{"facility":65,"status":47,"city":66,"state":39,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Haukeland University Hospital","Bergen","5021",{"type":54,"coordinates":69},[70,71],5.32415,60.39299,{"lat":71,"lon":70},[74],{"name":75,"role":37,"phone":76,"phoneExt":39,"email":77},"Eivind Strandenes, MD","55972771","eivind.strandenes@helse-bergen.no",{"facility":79,"status":80,"city":81,"state":39,"zip":82,"country":51,"countryCode":52,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Oslo University Hospital","RECRUITING","Oslo","0424",{"type":54,"coordinates":84},[85,86],10.74609,59.91273,{"lat":86,"lon":85},[89,93],{"name":90,"role":37,"phone":91,"phoneExt":39,"email":92},"Magne Røkkum, PhD, Prof","+4723070000","mrokkum@ous-hf.no",{"name":94,"role":37,"phone":95,"phoneExt":39,"email":96},"Sondre Hasselllund, MD","+4722118080","sondre.hassellund@gmail.com",{"facility":98,"status":47,"city":99,"state":39,"zip":100,"country":51,"countryCode":52,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"University Hospital of North Norway","Tromsø","9038",{"type":54,"coordinates":102},[103,104],18.95508,69.6489,{"lat":104,"lon":103},[107],{"name":108,"role":37,"phone":109,"phoneExt":39,"email":110},"Hebe Desiree Kvernmo, PhD, Prof","776 26000","hebe.kvernmo@gmail.com",{"facility":112,"status":47,"city":113,"state":39,"zip":114,"country":51,"countryCode":52,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University Hospital of St Olav","Trondheim","7006",{"type":54,"coordinates":116},[117,118],10.39506,63.43049,{"lat":118,"lon":117},[121],{"name":122,"role":37,"phone":123,"phoneExt":39,"email":124},"Heike Brigitta Zeitlemann, MD","+4772826000","heike.zeitlmann@stolav.no",{"facility":126,"status":80,"city":127,"state":128,"zip":129,"country":51,"countryCode":52,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Østfold Hospital Trust","Moss","Østfold fylke","1535",{"type":54,"coordinates":131},[132,133],10.65771,59.43403,{"lat":133,"lon":132},[136,138],{"name":33,"role":37,"phone":137,"phoneExt":39,"email":40},"+4769860000",{"name":42,"role":37,"phone":137,"phoneExt":39,"email":139},"jan-ragnar.haugstvedt@so-hf.no",{"type":34,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Istvan Zoltan Rigo","Consultant","100368250","norwegian-distal-ulna-resection---replacement-study-100368250",false,"NCT04074863","Norwegian Distal Ulna Resection - Replacement Study","Norwegian Distal Ulna Resection vs. Replacement Study. A Prospective Randomized Multicenter Study","NORDURR","Inclusion Criteria:\n\n* painful osteoarthritis distal radioulnar joint\n* stable DRUJ\n\nExclusion Criteria:\n\n* activ inflammatory disease with significant destruction of the joint\n* \"low demand\" persons\n* significant instability i DRUJ\n* active infections, poor soft tissue conditions\n* accidental wound on the operated hand\n* general contraindications for surgery","ALL","30 Years","75 Years",{"count":155,"type":156},40,"ESTIMATED","INTERVENTIONAL",[159],"NA","Osteoarthritis of the joint between the forearm bones at the wrist (distal radioulnar joint, DRUJ) is a common sequel of fracture and ligament injuries or degenerative disease of the wrist. Intact DRUJ is important for normal load transfer from the hand to the forearm. DRUJ osteoarthritis leads to pain and decreased lifting capacity and rotation of the forearm. The standard treatment is resection of the ulnar head, known as the Darrach procedure. After the resection there is no longer contact in the affected joint, however, some patients can experience instability or impingement between the forearm bones. With ulnar head implant replacement may the load transfer and the stability between the forearm bones less affected. Studies with good long term results are published with both resection and replacement. However, these methods were never compared and thus it is not clear, which of the methods gives the best clinical result and less complications.\n\nThe aim of this study is to compare Darrach procedure with ulnar head replacement in a prospective randomized multicenter study. Several hand surgical centers form Norway would participate this study.\n\nIndividuals seeking treatment for their stable but painful DRUJ joints will be included and randomized to either Darrach procedure or ulnar head implant. Participants will be followed up to 5 years. Range of motion and grip strength measures and functional scores would be registered before operation, after 3 months, 1 and 5 years. Eventual complications and reoperations would be also registered.",[162],"Osteoarthritis Wrist",[164,165,166,167,168],"Distal radioulnar joint","Darrach procedure","Ulnar head resection","Herbert prosthesis","Ulnar head replacement","2024-04-05",{"date":171,"type":172},"2024-04-08","ACTUAL",{"date":174,"type":172},"2020-09-16",{"date":176,"type":156},"2029-12-31",{"name":5,"class":6},6]