[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566374":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":43,"armGroups":44,"interventions":39,"overallOfficials":39,"centralContacts":51,"locations":59,"responsibleParty":79,"collaborators":39,"id":81,"slug":39,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":39,"enrollmentInfo":89,"targetDuration":39,"studyType":92,"phases":39,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":61,"whyStopped":39,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Reinier Haga Orthopedisch Centrum","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":39},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Pain","Pain will be measured each day in a diary for the first 8 weeks after surgery with the Numeric Rating Scale for Pain (NRS), which is a scale ranging from zero to ten on which patients can score their pain. It is a widely used instrument in varying populations due to its ease of administration and clinical relevance to the subject.","8 weeks",{"measure":14,"description":15,"timeFrame":12},"Function","Function will be measured each week in a diary for the first 8 weeks after surgery with the The Patient-Related Wrist\u002FHand Evaluation (PRWHE), which is a 15-item questionnaire concerning pain and function. Subjects are able to rate their pain and disabilities from zero to ten.",{"measure":17,"description":18,"timeFrame":12},"Quality of life (QoL)","QoL will be measured twice a week in a diary for the first 8 weeks after surgery with the EQ-5D, which is a general health-related quality-of-life questionnaire and consists of five questions regarding mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression and one visual analog scale (VAS) to document the perceived quality of life. It is also used to assess quality of life adjusted life years (QALY).",[20,24,27,30,33,36],{"measure":21,"description":22,"timeFrame":23},"Complications","Complications will be measured in the number of complications.","1 year",{"measure":25,"description":26,"timeFrame":12},"Pain medication","Pain medication will be measured with a diary during the first 8 weeks after surgery",{"measure":28,"description":29,"timeFrame":23},"PROMs - NRS","Patient-related outcome measurements (PROMs) will be measured with the NRS as part of the standard care. Numeric Rating Scale for Pain (NRS) is a scale ranging from zero to ten on which patients can score their pain. It is a widely used instrument in varying populations due to its ease of administration and clinical relevance to the subject.",{"measure":31,"description":32,"timeFrame":23},"PROMs - PRWHE","Patient-related outcome measurements (PROMs) will be measured with the PRWHE as part of the standard care. The Patient-Related Wrist\u002FHand Evaluation (PRWHE) is a 15-item questionnaire concerning pain and function. Subjects are able to rate their pain and disabilities from zero to ten.",{"measure":34,"description":35,"timeFrame":23},"PROMs - EQ5D","Patient-related outcome measurements (PROMs) will be measured with the EQ5D as part of the standard care. EQ-5D is a general health-related quality-of-life questionnaire and consists of five questions regarding mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression and one visual analog scale (VAS) to document the perceived quality of life. It is also used to assess quality of life adjusted life years (QALY). It has been translated into Dutch and validated in different populations.",{"measure":37,"description":38,"timeFrame":23},"PROMs - HADS","Patient-related outcome measurements (PROMs) will be measured with the HADS as part of the standard care. The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire concerning the mental state of the subject (i.e. anxiety and depression).",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":42,"maskingInfo":39},"COHORT","PROSPECTIVE","All consecutive eligible subjects will be asked to participate and devided into either the Trapeziectomy cohort or the TMC-arthroplasty cohort, depending on the scheduled operative treatment for the osteoarthrosis of the first carpometacarpal joint.",[45,48],{"label":46,"type":39,"description":47,"interventionNames":39},"Trapeziectomy","This cohort consist of patients receiving a trapeziectomy for arthrosis of the first carpometacarpal joint. The cohort will include 100 patients",{"label":49,"type":39,"description":50,"interventionNames":39},"TMC-arthroplasty","This cohort consist of patients receiving TMC-arthroplasty for arthrosis of the first carpometacarpal joint. The cohort will include 100 patients",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":39,"email":56},"Rianne Oomen","CONTACT","+31792065595","Onderzoek@rhoc.nl",{"name":58,"role":54,"phone":55,"phoneExt":39,"email":56},"Nina Mathijssen",[60],{"facility":5,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","Zoetermeer","South Holland","2725NA","Netherlands","NL",{"type":68,"coordinates":69},"Point",[70,71],4.49306,52.0575,{"lat":71,"lon":70},[74,75,76],{"name":53,"role":54,"phone":55,"phoneExt":39,"email":56},{"name":58,"role":54,"phone":55,"phoneExt":39,"email":56},{"name":77,"role":78,"phone":39,"phoneExt":39,"email":39},"Gerald Kraan","PRINCIPAL_INVESTIGATOR",{"type":80,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100566374",false,"NCT06654349","Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study","THUMB Diary","Inclusion Criteria:\n\n* Failed conservative treatment for osteoarthritis\n* Planned for trapeziectomy or TMC-joint arthroplasty\n* Age 18-75 years\n* Willing and able to comply with the postoperative functional assessment and to participate in a rehabilitation schedule\n\nExclusion Criteria:\n\n* Mentally disabled patients\n* Active infection\n* Current malignancy\n* Infiltration (corticoids \\\u003C 3 months)\n\nThe following criteria is specific for the TMC-joint arthroplasty group and is an addition to the criteria mentioned above:\n\n* Trapezium height \\\u003C 8 mm","ALL","18 Years",{"count":90,"type":91},200,"ESTIMATED","OBSERVATIONAL","Rationale: The trapeziometacarpal (TMC) joint is one of the most common areas in the hand and wrist to develop osteoarthritis (OA). Currently, the two most widely used procedures are the trapeziectomy and the TMC-joint arthroplasty, both with their own pros and cons. No studies have demonstrated superiority of TMC-joint arthroplasty over gold-standard trapeziectomy. And no clinical studies show short-term recovery and patient experience after trapeziectomy or TMC-joint arthroplasty.\n\nObjective: To gather insight in short-term recovery and patient experience after a trapeziectomy or TMC prosthesis regarding pain, pain medication, function and quality of life.\n\nStudy design: A prospective observational cohort diary study.\n\nStudy population: In total 200 subjects with TMC-joint osteoarthritis will participate: 100 subjects will have trapeziectomy and 100 subjects will have TMC-joint arthroplasty\n\nMain study parameters\u002Fendpoints: The main study parameters are the pain, function and quality of life during the first 8 weeks after surgery.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will have no direct benefit from participation in this study. Subjects will only complete a diary and questionnaires for this study. Therefore, we expect no risks from participation. The burden for subjects consists of approximately five minutes daily for the diary in the first eight weeks after surgery.",[95],"Arthrosis of First Carpometacarpal Joint",[46,97,49,98],"Diary","Osteoarthrosis","2025-05-20",{"date":101,"type":102},"2025-05-21","ACTUAL",{"date":104,"type":102},"2025-05-15",{"date":106,"type":91},"2030-12-31",{"name":5,"class":6},1]