[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636735":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":44,"locations":54,"responsibleParty":89,"collaborators":91,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":33,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":75,"whyStopped":33,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Uppsala University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 -Dual Mobility Prosthesis (TOUCH)","EXPERIMENTAL","TOUCH Total Joint Arthroplasty (n=42). Implantation of TOUCH trapeziometacarpal prosthesis (Kerimedical). Soft bandage for 3 weeks postoperatively, followed by rehabilitation per national guidelines.",[13],"Device: Implantation of trapeziometacarpal prosthesis",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2 - Trapeziectomy and Capsular Reconstruction","ACTIVE_COMPARATOR","Trapezectomy with capsuloplasty (n=42). Excision of trapezium with dorsal capsule flap capsuloplasty. Cast immobilization for 3 weeks postoperatively, followed by rehabilitation per national guidelines.",[19],"Procedure: Trapeziectomy with Capsuloplasty",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Implantation of trapeziometacarpal prosthesis","Surgical implantation of the TOUCH trapeziometacarpal total joint prosthesis (Kerimedical). The prosthesis consists of an uncemented stainless steel stem inserted into the first metacarpal and a dual cup mobility system with a polyethylene ball articulating against a metal cup fixed in the trapezium. The stem is available in straight or 15-degree angled neck configurations. Postoperative management consists of a stable soft dressing for 3 weeks to allow early controlled mobilization, followed by a standardized hand therapy rehabilitation protocol.",[9],[27],"TOUCH Dual-Mobility Prosthesis",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Trapeziectomy with Capsuloplasty","Surgical excision of the trapezium bone (trapeziectomy) followed by capsuloplasty using a distally based dorsal capsular flap, without tendon interposition. The capsular flap is sutured to stabilize the base of the first metacarpal. No implant or tendon graft is used. Postoperatively, a cast immobilizing the thumb in functional position is applied for 3 weeks, followed by a standardized hand therapy rehabilitation protocol.",[15],null,[35,39,42],{"name":36,"affiliation":37,"role":38},"Nils Hailer, MD, PhD. Professor","Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden","STUDY_DIRECTOR",{"name":40,"affiliation":37,"role":41},"Sara Edsfeldt, MD, PhD, senior attending","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":43},"STUDY_CHAIR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":33,"email":49},"Eva Nordin, Clinical research nurse","CONTACT","+46(0) 186119630","eva.nordin@akademiska.se",{"name":51,"role":47,"phone":52,"phoneExt":33,"email":53},"Elias Gardell, MD, attending hand surgeon","+46 (0) 186171544","elias.gardell@uu.se",[55,73],{"facility":56,"status":57,"city":58,"state":33,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Örebro university hospital","NOT_YET_RECRUITING","Örebro","Sweden","SE",{"type":62,"coordinates":63},"Point",[64,65],15.2066,59.27412,{"lat":65,"lon":64},[68,72],{"name":69,"role":47,"phone":70,"phoneExt":33,"email":71},"Eva Lundqvist, MD, PhD, senior attending","+46(0) 196025175","eva.lundqvist@regionorebrolan.se",{"name":69,"role":41,"phone":33,"phoneExt":33,"email":33},{"facility":74,"status":75,"city":76,"state":33,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Department of Handsurgery, Uppsala University Hospital","RECRUITING","Uppsala",{"type":62,"coordinates":78},[79,80],17.63889,59.85882,{"lat":80,"lon":79},[83,85,88],{"name":51,"role":47,"phone":84,"phoneExt":33,"email":53},"+46(0) 186171544",{"name":40,"role":47,"phone":86,"phoneExt":33,"email":87},"+46 (0) 186119031","sara.edsfeldt@uu.se",{"name":40,"role":41,"phone":33,"phoneExt":33,"email":33},{"type":90,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[92,95],{"name":93,"class":94},"Uppsala County Council, Sweden","OTHER_GOV",{"name":96,"class":94},"Örebro County Council","100636735","surgery-for-thumb-base-osteoarthritis-joint-replacement-vs-trapeziectomy-100636735",false,"NCT07569549","Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy","BASTION - BASe of Thumb Osteoarthritis Management Non-inferiority Trial: Surgical Treatment of First Carpometacarpal Joint Osteoarthritis: A Comparison Between Joint Replacement and Trapeziectomy","BASTION","Inclusion Criteria:\n\n* Age 40-80 years at inclusion\n* CMC-joint osteoarthritis grade 1-3 (Eaton-Littler classification)\n* Rest pain or pain reducing hand function with indication for surgery\n* Insufficient relief from non-operative treatment for ≥3 months (orthosis, OTC analgesics, cortisone injection)\n* Eligible for both prosthesis and trapezectomy per including surgeon\n* Non-smoker or complete smoking cessation ≥6 weeks prior to surgery\n\nExclusion Criteria:\n\n* Previous surgery to thumb base or STT-joint\n* Ongoing chronic pain condition\n* Dementia or cognitive impairment\n* Trapezium height \\\u003C7 mm on plain radiograph\n* Active smoker\n* Osteoarthritis grade 4 (Eaton-Littler)","ALL","40 Years","80 Years",{"count":109,"type":110},84,"ESTIMATED","INTERVENTIONAL",[113],"NA","The goal of this clinical trial is to learn if the surgical method with total joint arthroplasty, (TOUCH joint prosthesis), is as good as or better than the traditional surgical method, trapezectomy, to treat thumb base joint osteoarthritis.\n\nThe main questions it aims to answer are:\n\nDoes surgery with total joint arthroplasty provide better power grip and pinch grip strength compared to traditional surgery?\n\nWhat is the long-term risk of complications for both methods?\n\nWhich method is more cost-effective for the healthcare system?\n\nResearchers will compare total joint arthroplasty (TOUCH) to trapezectomy (a procedure where a bone in the thumb base is removed) to see which method provides the best results for the patient.\n\nParticipants will:\n\nBe randomized to undergo either an operation with total joint arthroplasty or a trapezectomy.\n\nUndergo an initial evaluation and a health economic cost analysis after one year.\n\nAttend follow-up checkups at 2, 5, and 10 years post-surgery to evaluate long-term function and the durability of the prosthesis.",[116,117,118,119],"Thumb Osteoarthritis","Thumb Carpometacarpal Joint Osteoarthritis","Carpometacarpal (CMC) Joint Arthritis","Basal Thumb Osteoartrithis",[121,122,123,124,125,126,127,116,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149],"Thumb base arthroplasty","CMC joint","prosthesis","hand surgery","First Carpometacarpal Joint","Trapeziometacarpal Joint","Rhizarthrosis","Dual Mobility Prosthesis","Total Joint Replacement","Total Joint Arthroplasty","Ligament Reconstruction","Surgical Reconstruction","Randomized Controlled Trial (RCT)","Prospective Studies","Comparative Study","Prospective Study","Cost-Effectiveness Analysis","Cost-Benefit Analysis","Health Economics","Patient Reported Outcome Measures (PROMs)","Quality of Life (QoL)","Health-Related Quality of Life (HRQoL)","Return to Work","Grip Strength","Pinch Strength","QuickDASH","EQ-5D","Michigan Hand Outcomes Questionnaire (MHQ","Trapeziectomy","2026-06-22",{"date":152,"type":153},"2026-06-25","ACTUAL",{"date":155,"type":110},"2026-07-01",{"date":157,"type":110},"2038-03",{"name":5,"class":6},2]