[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461604":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":66,"collaborators":42,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":42,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"NHS Lothian","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Manual Total Knee Arthroplasty","ACTIVE_COMPARATOR","This group will receive a conventional manual Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert. The surgeon will then make bone cuts using a manual jig and a hand held saw to prepare the bone surfaces for the implant. A measured resection technique will be employed with a three degree tibial slope. The surgeon will use a conventional jig alignment technique for intramedullary referencing for the femur and extra medullary referencing for the tibia. Once the implant is in position the knee is then balanced by the \"feel\" though a range of movement and soft tissue releases will be performed as required to balance the knee in flexion and extension.",[13],"Device: Triathlon (Stryker) Total Knee Arthroplasty",{"label":15,"type":16,"description":17,"interventionNames":18},"Robotic Assisted Unicompartmental Knee Arthroplasty","EXPERIMENTAL","This group will receive the cemented Restoris MCK (Mako, Stryker) with a highly crossed linked (X3) polyethylene insert through a less invasive to the knee joint. Instead of using a manual jig and a hand held burr will be used to prepare the bone surfaces for the implant, the MAKO robotic arm will be used by the surgeon to cut the bone at the required alignment. The information from the CT scan will be used to create a 3D model of the patient's bony anatomy and will used to plan the positioning of the implant. Once the trackers are in place registration of the knee joint surface is performed. The specified bone cuts are then performed using the robotic arm, aiming to gap balance the knee through a full range of movement.",[19],"Device: MAKO™ Partial Knee Arthroplasty",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","MAKO™ Partial Knee Arthroplasty","The robotic-arm will be used to position a partial knee arthroplasty.",[15],[27],"Robotic-arm assisted partial knee arthroplasty",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Triathlon (Stryker) Total Knee Arthroplasty","Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert.",[9],[33],"Total Knee Replacement",[35],{"name":36,"affiliation":5,"role":37},"Nicholas D Clement, MD, PhD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+44 131 536 1000",null,"nick.clement@nhslothian.scot.nhs.uk",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"James T Patton, FRCS","Sam.Patton@nhslothian.scot.nhs.uk",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Nicholas Clement","RECRUITING","Edinburgh","Lothian","EH16 6SA","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-3.19648,55.95206,{"lat":60,"lon":59},[63,65],{"name":36,"role":40,"phone":64,"phoneExt":42,"email":43},"(+44)131 536 1000",{"name":45,"role":40,"phone":64,"phoneExt":42,"email":46},{"type":67,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100461604","total-versus-robotic-assisted-unicompartmental-knee-replacement-100461604",false,"NCT05290818","Total Versus Robotic Assisted Unicompartmental Knee Replacement","Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial","TRAKER","Inclusion Criteria:\n\n* Listed for elective primary TKA for end stage medial compartment osteoarthritis\n* Intact anterior cruciate ligament\n* Full thickness and good quality lateral cartilage\n* Correctable intra-articular varus deformity and intact medial collateral ligament\n* American Society of Anesthesiologists (ASA) grades 1 and 2\n* Male or female, age 50 - 75 at the time of listing for surgery\n* Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA\n\nExclusion Criteria:\n\n* Varus deformity of \\> 20 degrees\n* Fixed flexion of \\>10 degrees\n* Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments\n* Female participants who are pregnant, lactating or planning pregnancy during the course of the study\n* Requires patella resurfacing or lateral compartment has significant OA\n* Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons\n* Inflammatory disorder e.g. rheumatoid arthritis\n* Symptomatic foot, hip or spine pathology\n* Prior surgery (other than arthroscopy) or septic arthritis of the knee\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,","ALL","50 Years","75 Years",{"count":80,"type":81},159,"ESTIMATED","INTERVENTIONAL",[84],"NA","The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.",[87,88,89],"Osteo Arthritis Knee","Arthritis Knee","Arthropathy of Knee",[91,92,93,94,95,96,97],"Arthroplasty","Robotic","Knee","Total","Partial","Outcome","MAKO","2026-02-04",{"date":100,"type":101},"2026-02-06","ACTUAL",{"date":103,"type":101},"2024-08-26",{"date":105,"type":81},"2027-12-31",{"name":5,"class":6},1]