[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635449":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":26,"responsibleParty":45,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":26,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Sahlgrenska University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trapeziometacarpal joint arthroplasty","EXPERIMENTAL","Implantation of the Touch® CMC-1 prosthesis",[13],"Procedure: trapeziometacarpal arthroplasty",{"label":15,"type":16,"description":17,"interventionNames":18},"Trapeziectomy","ACTIVE_COMPARATOR","Surgical excision of the trapezium",[13,19],"Procedure: Trapeziectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","trapeziometacarpal arthroplasty","Participants allocated to arthroplasty will undergo implantation of the Touch® CMC-1 prosthesis according to routine practice at the study site. Surgery will be performed by experienced hand surgeons. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free.",[15,9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Participants allocated to trapeziectomy will undergo surgical excision of the trapezium without tendon interposition according to routine practice at the study site. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free",[15],[31],{"name":32,"affiliation":33,"role":34},"Joakim Stromberg, MD, PhD","Sahlgrenska University Hospital, University of Gothenburg","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Joakim Stromberg, Md,PhD","CONTACT","+46768341327","joakim.stromberg@vgregion.se",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Victoria Wängberg, MD","+46739804631","victoria.wangberg@vgregion.se",{"type":34,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Joakim Stromberg","Associate Professor",[49],{"name":50,"class":51},"Vastra Gotaland Region","OTHER_GOV","100635449","trapeziometacarpal-joint-arthroplasty-versus-trapeziectomy-for-thumb-carpometacarpal-osteoarthritis-100635449",false,"NCT07552831","Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis","T3","Inclusion Criteria:\n\n* Pain at the base of the thumb affecting activities of daily living and insufficient response to at least 3 months of non-operative treatment (orthosis, non-steroidal anti-inflammatory drugs, and\u002For corticosteroid injections).\n* Radiographic thumb carpometacarpal osteoarthritis, Eaton grade 2-3.\n* For Eaton grade 2, age ≥50 years.\n* Age 18-69 years.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Symptomatic osteoarthritis of adjacent joints (e.g., scaphotrapeziotrapezoid joint, STT-joint).\n* Need for concurrent surgery in the metacarpophalangeal joint (e.g. arthrodesis or capsulodesis).\n* Post-traumatic thumb carpometacarpal osteoarthritis.\n* Previous surgery for thumb carpometacarpal osteoarthritis in the contralateral hand.\n* Inflammatory arthritis (e.g., rheumatoid arthritis or systemic lupus erythematosus).\n* Osteoporosis\u002Fosteopenia of such severity that secure cup placement in the trapezium is not possible (for arthroplasty).\n* Ongoing systemic corticosteroid treatment.\n* Other hand surgical condition in the same hand that could confound outcomes (e.g., carpal tunnel syndrome or de Quervain tenosynovitis).\n* Cognitive impairment preventing reliable participation.\n* Ongoing, or suspected ongoing, alcohol or drug misuse.\n* Insufficient Swedish language proficiency to complete the questionnaires.",true,"ALL","18 Years",{"count":63,"type":64},64,"ESTIMATED","INTERVENTIONAL",[67],"NA","Thumb carpometacarpal osteoarthritis is common and may cause severe pain and functional limitation. Trapeziectomy is widely used, whereas prosthetic arthroplasty may offer faster early recovery. However, detailed information on early postoperative and long-term radiological outcomes remains limited.\n\nThis is a single-centre, blinded randomised controlled trial at Sahlgrenska University Hospital, Gothenburg, Sweden. Adults aged 18-69 years with symptomatic thumb carpometacarpal osteoarthritis (Eaton grade 2-3) refractory to at least 3 months of non-operative treatment will be randomised 1:1 to trapeziometacarpal prosthetic arthroplasty or trapeziectomy. The primary outcome is day-by-day pain (registration on a numeric rating scale NRS, 0-10). Secondary outcomes include day-by-day analgesic consumption for 90 days, orthosis use after cast removal, patient-reported function (HQ-8, QuickDASH, and Nelson score) at 30, 45, 60, 75 and 90 days, assessor-measured range of motion and strength at 45 and 90 days, and long-term clinical follow-up at 6 months and 1, 2, 5 and 10 years. Cone beam computed tomography will be obtained in the arthroplasty group at 1 week postoperatively as reference and at 6 months and 1, 2, 5 and 10 years to assess implant position, migration and loosening. The target sample size is 64 participants (32 per group), providing 95% power to detect a 1-point between-group difference on the pain scale. Analyses will follow the intention-to-treat principle.",[70],"Thumb Osteoarthritis","NOT_YET_RECRUITING","2026-04-30",{"date":74,"type":75},"2026-05-01","ACTUAL",{"date":77,"type":64},"2026-09-01",{"date":79,"type":64},"2038-12-31",{"name":5,"class":6}]