[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444040":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":76,"collaborators":25,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":25,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":25,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"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",[42,61],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Lindenhofgruppe AG - Orthopädie Sonnenhof","RECRUITING","Bern","3006","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],7.44744,46.94809,{"lat":53,"lon":52},[56,59],{"name":57,"role":38,"phone":25,"phoneExt":25,"email":58},"Annabel Hayoz","annabel.hayoz@lindenhofgruppe.ch",{"name":60,"role":34,"phone":25,"phoneExt":25,"email":25},"Matthias A Zumstein, Prof Dr med",{"facility":62,"status":44,"city":63,"state":25,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen","Sankt Gallen","9007",{"type":50,"coordinates":66},[67,68],9.37477,47.42391,{"lat":68,"lon":67},[71,74],{"name":72,"role":38,"phone":25,"phoneExt":25,"email":73},"Vilijam Zdravkovic, MD","Vilijam.Zdravkovic@kssg.ch",{"name":75,"role":34,"phone":25,"phoneExt":25,"email":25},"Bernhard Jost, Prof Dr. med",{"type":77,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100444040","mirror-medacta-shoulder-system-pivotal-trial-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":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"NA","The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.",[95,96],"Arthritis Shoulder","Post-traumatic Arthrosis of Other Joints, Upper Arm","2025-05-07",{"date":99,"type":100},"2025-05-08","ACTUAL",{"date":102,"type":100},"2022-01-05",{"date":104,"type":89},"2027-12-30",{"name":5,"class":6},2]