[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635374":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":49,"locations":56,"responsibleParty":80,"collaborators":82,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":26,"enrollmentInfo":98,"targetDuration":26,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":113,"overallStatus":117,"whyStopped":26,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Golden Jubilee National Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VELYS Robotic-Assisted Total Knee Replacement","EXPERIMENTAL","Trial treatment, with an ATTUNE total knee replacement put in by a surgeon using robot-assistance for the bone cuts from the VELYS robot, allowing for functional alignment to be used.",[13],"Device: Robot-Assisted Functionally Aligned Total Knee Replacement",{"label":15,"type":16,"description":17,"interventionNames":18},"Manual Non-Robotic Total Knee Replacement","ACTIVE_COMPARATOR","Current standard treatment, with an ATTUNE total knee replacement put in by a surgeon with no robot assistance, using manually-achievable alignment strategies.",[19],"Procedure: Manual Total Knee Arthroplasty",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Robot-Assisted Functionally Aligned Total Knee Replacement","This device is a semi-active image-free arthroplasty robot that is under the full control of the surgeon at all times, but helps to make certain parts of the operation more accurate (bone cuts). The device will allow for use of so-called functional alignment. The implant put into the knee (ATTUNE total knee replacement) is the same for either of the techniques used (traditional method or VELYS robot). It has an excellent track record and is widely used in the UK and throughout the world.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Manual Total Knee Arthroplasty","This will be a manual total knee replacement carried out in standard fashion using ATTUNE implants with a good UK and worldwide track record. Alignment philosophies used will be manually achievable.",[15],[33,37,40,43,46],{"name":34,"affiliation":35,"role":36},"Jon V Clarke, PhD, FRCS (Tr & Orth)","Golden Jubilee University National Hospital","STUDY_CHAIR",{"name":38,"affiliation":39,"role":36},"Nick D Clement, MD, PhD, FRCS (Tr & Orth)","Edinburgh Orthopaedics, Royal Infirmary of Edinburgh",{"name":41,"affiliation":42,"role":36},"Andrew J Hall, PhD, MBChB, MRCS (Ed.)","University of St Andrews",{"name":44,"affiliation":35,"role":45},"Joanne McGarry","STUDY_DIRECTOR",{"name":47,"affiliation":35,"role":48},"Christopher Gee, MSc, FRCS (Tr & Orth), MFSTEd","PRINCIPAL_INVESTIGATOR",[50,54],{"name":34,"role":51,"phone":52,"phoneExt":26,"email":53},"CONTACT","+44 (0)141 951 5564","jon.clarke@gjnh.scot.nhs.uk",{"name":41,"role":51,"phone":26,"phoneExt":26,"email":55},"ajh52@st-andrews.ac.uk",[57],{"facility":35,"status":26,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Glasgow","Scotland","G81 4HX","United Kingdom","UK",{"type":64,"coordinates":65},"Point",[66,67],-4.25763,55.86515,{"lat":67,"lon":66},[70,75,78],{"name":71,"role":51,"phone":72,"phoneExt":73,"email":74},"Catherine Sinclair","+44 (0) 141 951 5440","5440","catherine.sinclair@gjnh.scot.nhs.uk",{"name":44,"role":51,"phone":72,"phoneExt":76,"email":77},"5269","Joanne.McGarry@gjnh.scot.nhs.uk",{"name":79,"role":48,"phone":26,"phoneExt":26,"email":26},"Christopher Gee, MBChB, MSc, FRCSEd (Tr&Orth)",{"type":81,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[83,86],{"name":84,"class":85},"Johnson & Johnson","INDUSTRY",{"name":87,"class":85},"DePuy Orthopaedics","100635374","manual-arthroplasty-versus-velys-robotic-assisted-solution-functional-alignment-arthroplasty-for-knee-osteoarthritis-100635374",false,"NCT07551856","Manual Arthroplasty Versus VELYS Robotic-Assisted Solution Functional Alignment Arthroplasty for Knee Osteoarthritis","Manual Arthroplasty Versus VELYS Robotic-Assisted Solution Functional Alignment Arthroplasty for Knee Osteoarthritis (The MARVEL Project): A Pragmatic, Multicentre, Blinded Randomised Controlled Trial With Multi-domain Investigations","MARVEL Project","Inclusion Criteria:\n\n* Aged \\>18 years\n* Primary knee OA\n* Requiring TKA\n* Suitable for either raTKA or mTKA\n* Capable to provide written informed consent\n* Capable and willing to complete outcome measures throughout study period\n\nExclusion Criteria:\n\n* Inflammatory arthritis\n* Significant symptomatic hip, ankle, or contralateral knee OA\n* Prior TKA or major injury or major surgery on the index knee\n* Neuromuscular gait disorders\n* BMI \\>45 kg\u002Fm2\n* Coronal plane deformity \\>15° varus\u002Fvalgus on pre-op HKA radiograph\n* Fixed flexion deformity greater than 15°\n* Bone loss likely to require non-standard implants (e.g. stems, augments)\n* Severe deformity or ligament insufficiency likely to require constraint\n* Inability to comply with the required follow-up assessments or complete PROMs\n* Contraindications to any aspect of the surgical technique","ALL","18 Years",{"count":99,"type":100},346,"ESTIMATED","INTERVENTIONAL",[103],"NA","The goal of this clinical trial is to learn if the VELYS Robotic-Assisted Solution (VRAS) device helps to improve outcomes from total knee replacement, when compared to regular non-robotic-assisted total knee replacement in the treatment of osteoarthritis. It will also aim to review the longer-term safety and efficiency effects of using this device.\n\nThe main questions it aims to answer are:\n\n1. Does VRAS device-assisted total knee replacement improve patient outcomes (such as their function, satisfaction, and pain) when compared to non-robotic-assisted total knee replacement?\n2. Does VRAS device-assisted total knee replacement improve clinical outcomes (such as revision risk, complications, and hospital length of stay) when compared to non-robotic-assisted total knee replacement?\n3. Does VRAS device-assisted total knee replacement improve functional outcomes (including biomechanical motion analysis) when compared to non-robotic-assisted total knee replacement?\n4. What are the economic and efficiency effects of VRAS device-assisted total knee replacement compared to non-robotic-assisted total knee replacement?\n5. What are the human factor and learning curve effects of introducing VRAS device-assisted total knee replacement into healthcare teams?\n6. Are there any differences in safety and adverse event incidence between VRAS device-assisted total knee replacement and non-robotic-assisted total knee replacement?\n\nParticipants will:\n\n* Be randomised to receive a total knee replacement using either regular non-robotic-assisted methods, or with the use of the VRAS device.\n* Be assessed pre-operatively at the clinic, and then at 6 weeks, 6 months, and 12 months following date of operation. At these appointments patients will answer questionnaires, receive an x-ray (pre-operatively, and at 6 months post-operatively), and a subgroup will be reviewed in the motion analysis laboratory (pre-operatively, and at 6 months post-operatively).\n* Have their longer-term outcomes including any revision operations monitored out to 10 years through national registry data linkage (no actual follow-up for patients after 12 months).",[106,107,108,109,110,111,112],"Knee Osteoarthritis","Osteoarthritis (Knee)","Osteo Arthritis of the Knee","Osteo Arthritis","Osteoarthritis (OA)","Osteoarthritis","Osteoarthritis in the Knee",[114,111,115,116],"Knee","Robotic","Alignment","NOT_YET_RECRUITING","2026-04-28",{"date":120,"type":121},"2026-05-04","ACTUAL",{"date":123,"type":100},"2026-05-08",{"date":125,"type":100},"2030-05-08",{"name":5,"class":6},1]