[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624157":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":99,"collaborators":101,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":10,"enrollmentInfo":115,"targetDuration":10,"studyType":118,"phases":10,"briefSummary":119,"conditions":120,"keywords":10,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Keri Medical SA","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"TOUCH® CMC 1 Prosthesis",null,[12],"Device: TOUCH® CMC 1 Prosthesis",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":10},"DEVICE","The TOUCH® CMC 1 Prosthesis is a commercially available thumb joint implant which is made up of three modular components:\n\n1. TOUCH Cup: a stainless steel trapezial implant (cup) with a dual coating of plasma sprayed titanium and hydroxyapatite; TOUCH Cup is available in two options: Spherical and Conical\n2. TOUCH Liner and Neck: a junction implant (neck) topped with a liner pre-assembled to stainless steel neck\n3. TOUCH Stem: a titanium alloy metacarpal implant (stem) with a dual coating of plasma sprayed titanium and hydroxyapatite",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Deborah Caux","CONTACT","+41 58 611 0062","Deborah.Caux@kerimedical.com",[25,47,64,81],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"University of Colorado, Anschutz School of Medicine","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-104.83192,39.72943,{"lat":37,"lon":36},[40,44],{"name":41,"role":21,"phone":42,"phoneExt":10,"email":43},"Layla Haji","720-579-8971","layla.haji@ucdenver.edu",{"name":45,"role":46,"phone":10,"phoneExt":10,"email":10},"Louis W Catalano III, MD","PRINCIPAL_INVESTIGATOR",{"facility":48,"status":27,"city":49,"state":50,"zip":51,"country":31,"countryCode":32,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Indiana Hand to Shoulder Center","Indianapolis","Indiana","46260",{"type":34,"coordinates":53},[54,55],-86.15804,39.76838,{"lat":55,"lon":54},[58,62],{"name":59,"role":21,"phone":60,"phoneExt":10,"email":61},"Melanie Glover","463-249-2613","mglover@orthoindy.com",{"name":63,"role":46,"phone":10,"phoneExt":10,"email":10},"Thomas Kaplan, MD",{"facility":65,"status":27,"city":66,"state":67,"zip":68,"country":31,"countryCode":32,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Duke University Medical Center, Department of Orthopaedic Surgery","Morrisville","North Carolina","27560",{"type":34,"coordinates":70},[71,72],-78.82556,35.82348,{"lat":72,"lon":71},[75,79],{"name":76,"role":21,"phone":77,"phoneExt":10,"email":78},"Jacob Carpenter","919-660-5017","jacob.carpenter@duke.edu",{"name":80,"role":46,"phone":10,"phoneExt":10,"email":10},"Tyler Pidgeon, MD",{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":31,"countryCode":32,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University of Texas Health San Antonio, Department of Orthopaedics","NOT_YET_RECRUITING","San Antonio","Texas","78229",{"type":34,"coordinates":88},[89,90],-98.49363,29.42412,{"lat":90,"lon":89},[93,97],{"name":94,"role":21,"phone":95,"phoneExt":10,"email":96},"Nick Lucio","210-567-5142","luciond@uthscsa.edu",{"name":98,"role":46,"phone":10,"phoneExt":10,"email":10},"Brian Sager, MD",{"type":100,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[102],{"name":103,"class":104},"MCRA (an IQVIA business)","UNKNOWN","100624157","touch-cmc-1-new-enrollment-us-study-100624157",false,"NCT07405983","TOUCH® CMC 1 New Enrollment US Study","Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study","PAS002","Inclusion Criteria:\n\n1. Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)\n2. Adult (≥ 22 years of age) at the time of enrollment\n3. Willing and able to sign the study Informed Consent\n\nExclusion Criteria:\n\n1. Acute or chronic infections, local or systemic\n2. Muscular, neurological, or vascular severe deficiency affecting the joint\n3. Inadequate bone quality or quantity preventing the implant fixation\n4. Bones dimensions incompatible with implant sizes\n5. Patients who are allergic to the product's materials\n6. Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)\n7. Skeletally immature (i.e., pediatric population, \\\u003C22 years of age)\n8. Pregnant or nursing women\n9. Patients with contraindications to surgery in general\n10. Patients with an intellectual disability who cannot follow the instructions of their surgeon.","ALL","22 Years",{"count":116,"type":117},163,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort.",[121,122],"Osteoarthritis Thumb","Thumb Carpometacarpal Joint Osteoarthritis","2026-06-02",{"date":125,"type":126},"2026-06-04","ACTUAL",{"date":128,"type":126},"2026-03-04",{"date":130,"type":117},"2030-02",{"name":5,"class":6},4]