[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444040":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":75,"collaborators":25,"id":77,"slug":25,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":25,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":25,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Medacta International SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mirror group","EXPERIMENTAL","Mirror Medacta Shoulder System",[13],"Device: Mirror Medacta Shoulder System",{"label":15,"type":16,"description":17,"interventionNames":18},"Historical Control group","ACTIVE_COMPARATOR","Total shoulder arthroplasty system",[19],"Device: Medacta Shoulder System",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Anatomic total shoulder arthroplasty system",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Medacta Shoulder System","Anatomic total shoulder arthroplasty system - standard configuration",[15],[31],{"name":32,"affiliation":33,"role":34},"Matthias A Zumstein, Prof Dr. med","Lindenhofgruppe AG (Bern)","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Marco Viganò, PhD","CONTACT","+41 091 6966060","m.vigano@medacta.ch",[42,60],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Lindenhofgruppe AG - Orthopädie Sonnenhof","RECRUITING","Bern","3006","Switzerland",{"type":49,"coordinates":50},"Point",[51,52],7.44744,46.94809,{"lat":52,"lon":51},[55,58],{"name":56,"role":38,"phone":25,"phoneExt":25,"email":57},"Annabel Hayoz","annabel.hayoz@lindenhofgruppe.ch",{"name":59,"role":34,"phone":25,"phoneExt":25,"email":25},"Matthias A Zumstein, Prof Dr med",{"facility":61,"status":44,"city":62,"state":25,"zip":63,"country":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen","Sankt Gallen","9007",{"type":49,"coordinates":65},[66,67],9.37477,47.42391,{"lat":67,"lon":66},[70,73],{"name":71,"role":38,"phone":25,"phoneExt":25,"email":72},"Vilijam Zdravkovic, MD","Vilijam.Zdravkovic@kssg.ch",{"name":74,"role":34,"phone":25,"phoneExt":25,"email":25},"Bernhard Jost, Prof Dr. med",{"type":76,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100444040",false,"NCT05062252","Mirror Medacta Shoulder System Pivotal Trial","Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.","Inclusion Criteria:\n\n* Age ≥ 18 yr\n* Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and\u002For posttraumatic arthritis\n* Willingness and ability to comply with study protocol\n\nExclusion Criteria:\n\n* Medical condition or balance impairment that could lead to falls\n* Prior rotator cuff surgery\n* Cuff tear arthropathy\u002Finsufficient rotator cuff\n* Insufficient bone quality which may affect the stability of the implant\n* Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes\n* Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation\n* Active metastatic or neoplastic disease at the shoulder joint\n* Chemotherapy treatment\u002Fradiotherapy within 6 mo before surgery\n* \\>5 mg\u002Fday of corticosteroids, excluding inhalers, within 3 years before surgery\n* Pregnancy or plan to become pregnant during study period\n* Inability to understand study or a history of noncompliance with medical advice\n* Alcohol or drug abuse\n* Current enrollment in any clinical research study that might interfere with this study\n* Metal allergies or sensitivity.\n* Previous or current infection at or near the site of implantation.\n* Current distant or systemic infection\n* Patient, whose infomed consent form should be taken in an emergency situation\n* ONLY for women of childbearing age: a positive pregnancy test (urine \u002F blood)","ALL","18 Years",{"count":86,"type":87},100,"ESTIMATED","INTERVENTIONAL",[90],"NA","The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.",[93,94],"Arthritis Shoulder","Post-traumatic Arthrosis of Other Joints, Upper Arm","2025-05-07",{"date":97,"type":98},"2025-05-08","ACTUAL",{"date":100,"type":98},"2022-01-05",{"date":102,"type":87},"2027-12-30",{"name":5,"class":6},2]