[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544664":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":40,"locations":49,"responsibleParty":65,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":10,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":10,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Limacorporate S.p.a","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adult patients requiring a primary TSA or RSA",null,"Device: PRIMA humeral stem in anatomic or reverse configuration Shoulder arthroplasty according to the instruction for use.",[13],"Device: Shoulder Arthroplasy with PRIMA humeral stem",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Shoulder Arthroplasy with PRIMA humeral stem","Data collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration)",[9],[21,25,28,31,34,37],{"name":22,"affiliation":23,"role":24},"Alessandro Castagna","Humanitas Rozzano, Italy","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Paolo Paladini","Unit of Shoulder Surgery Romagna\u002F Cervesi Hospital, Italy",{"name":29,"affiliation":30,"role":24},"Jörn Kircher","ATOS Klinik Fleetinsel Hamburg, Germany",{"name":32,"affiliation":33,"role":24},"Amar Malhas","Royal Berkshire NHS Trust, UK",{"name":35,"affiliation":36,"role":24},"Fernando Marco Martinez","Hospital Clinico San Carlos, Spain",{"name":38,"affiliation":39,"role":24},"Iain Packham","North Bristol NHS Trust, UK",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Camilla Vianello","CONTACT","+390432945357","camilla.vianello@limacorporate.com",{"name":47,"role":43,"phone":44,"phoneExt":10,"email":48},"Francesca Citossi","francesca.citossi@limacorporate.com",[50],{"facility":27,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Cattolica","Rimini","47841","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],12.73631,43.96182,{"lat":61,"lon":60},[64],{"name":26,"role":43,"phone":10,"phoneExt":10,"email":10},{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100544664","prima-eu-retrospective--prospective-100544664",false,"NCT06371833","PRIMA EU Retrospective & Prospective","A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Full skeletal maturity;\n3. Life expectancy over 24 months;\n4. Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle;\n5. Patient meets at least one of the following indications:\n\n   For Anatomic configuration:\n   * non-inflammatory degenerative joint disease (i.e., osteoarthritis);\n   * inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;\n   * avascular necrosis of the humeral head;\n   * cuff tear arthropathy (CTA Heads only);\n\n   For Reverse configuration:\n   * rotator cuff tear arthropathy;\n   * osteoarthritiswith rotator cuff tear;\n   * rheumatoid arthritis with rotator cuff tear;\n   * massive irreparable rotator cuff tear;\n6. Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;\n7. Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities.\n\nExclusion Criteria:\n\n1. Patients who lack capacity to be able to provide informed consent to participate in the study.\n2. Local or systemic general infection;\n3. Septicaemia;\n4. Persistent acute or chronic local or systemic osteomyelitis;\n5. Confirmed neurologic lesion compromising shoulder joint function;\n6. Deltoid muscle insufficiency;\n7. Poor meta-epiphyseal bone stock compromising stability of the implant (severe fracture of the proximal humerus, meta-epiphyseal pseudoarthrosis, osteoporosis, osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery);\n8. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course;\n9. Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant;\n10. Proximal humerus fracture sequelae with inadequate bone stock;\n11. Vascular or nerve diseases affecting the concerned limb;\n12. Metabolic disorders which may impair fixation and stability of the implant;\n13. Any concomitant disease that might affect the implanted prosthesis;\n14. Metal hypersensitivity to implant materials (CoCrMo);\n15. Patient with significant renal impairment;\n16. Lower mobility issues that may affect the study evaluation;\n17. Unwillingness or inability (due to physical or mental issues) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;\n18. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant;\n19. Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.","ALL","18 Years",{"count":77,"type":78},60,"ESTIMATED","OBSERVATIONAL","This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.",[82,83,84],"Arthroplasty","Replacement","Shoulder",[86,87,88],"TSA","RSA","Shoulder replacement","2025-02-03",{"date":91,"type":92},"2025-02-05","ACTUAL",{"date":94,"type":92},"2024-10-25",{"date":96,"type":78},"2026-12",{"name":5,"class":6},1]