[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463414":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":27,"locations":10,"responsibleParty":36,"collaborators":10,"id":38,"slug":10,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":10,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":10,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":61,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":10},{"fullName":5,"class":6},"Limacorporate S.p.a","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SMR TT Hybrid Glenoid without Cementless Finned Short Stem",null,"Patients implanted with SMR TT Hybrid Glenoid without Cementless Finned Short Stem",[13],"Device: SMR TT Hybrid Glenoid without Cementless Finned Short Stem",{"label":15,"type":10,"description":16,"interventionNames":17},"SMR TT Hybrid Glenoid with Cementless Finned Short Stem","Patients implanted with SMR TT Hybrid Glenoid with Cementless Finned Short Stem",[18],"Device: SMR TT Hybrid Glenoid with Cementless Finned Short Stem",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":10},"The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation.\n\nThe fins are intended to enhance press-fit fixation. The same proximal morse taper is used for coupling to the same humeral bodies in the SMR Shoulder System. The SMR finned short stem is intended for cementless fixation.",[15],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Laura Sanchez","CONTACT","817-233-1686","laura.sanchez@limacorporate.com",{"name":34,"role":30,"phone":31,"phoneExt":10,"email":35},"Ryan Bacchus","ryan.bacchus@limacorporate.com",{"type":37,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100463414",false,"NCT05314387","S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem","A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem","Inclusion Criteria:(Key)\n\n* Both genders;\n* Age ≥ 18 years old;\n* Full skeletal maturity;\n* Life expectancy over 5 years;\n* Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;\n* Good bone quality evaluated by the Investigator and the intraoperative evaluation;\n* A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:\n\n  1. Primary osteoarthritis;\n  2. Secondary osteoarthritis;\n  3. Post-traumatic arthritis;\n  4. Rheumatoid arthritis;\n  5. Avascular necrosis\n  6. acute fractures of the humeral head that cannot be treated with other fracture fixation methods;\n  7. cuff tear arthropathy (only in combination with CTA Heads);\n  8. Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.\n\nExclusion Criteria (Key):\n\n* Patient requiring revision shoulder arthroplasty;\n* Osteoporosis with a history of non-traumatic fractures;\n* Steroid injections within the previous 3 months;\n* Contralateral shoulder replacement within the previous 3 months;\n* Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;\n* Significant neurological or musculoskeletal disorders that may compromise functional recovery;\n* Not recovered axillary nerve palsy;\n* Non functioning deltoid muscle;\n* Known or suspicious hypersensitivity to the metal or other components and materials of the implant;\n* Participation in any experimental drug\u002Fdevice study within the 6 months prior to the preoperative visit;\n* Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.\n\nThese are key eligibility criteria, other eligibility criteria apply.","ALL","18 Years",{"count":47,"type":48},100,"ESTIMATED","OBSERVATIONAL","Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem",[52,53,54,55,56,57,58,59,60],"Shoulder Arthritis","Shoulder Osteoarthritis","Arthrosis","Osteoarthritis","Rheumatoid Arthritis","Arthroplasty","Avascular Necrosis","Humeral Fractures","Cuff Tear Arthropathy",[62,63,64,65],"Shoulder Joint","Shoulder Replacement","Arthritis with rotator cuff tear","Post traumatic fracture sequele","NOT_YET_RECRUITING","2022-03-29",{"date":69,"type":70},"2022-04-06","ACTUAL",{"date":72,"type":48},"2022-04",{"date":74,"type":48},"2029-04",{"name":5,"class":6}]