[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476694":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Total Shoulder Arthroplasty (anatomic) + augmented glenoid component","ACTIVE_COMPARATOR","TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. An additional surgical technique, \"augmented glenoid component\" implantation is performed when there is missing bone in the shoulder and is currently being done as standard of care. This technique is used particularly when a large amount of instability within the shoulder joint is present. This technique attempts to realign and restore balance to the shoulder joint using artificial components.",[13],"Procedure: Total Shoulder Arthroplasty + augmented glenoid component",{"label":15,"type":10,"description":16,"interventionNames":17},"Reverse Shoulder Arthroplasty","RSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position",[18],"Procedure: Reverse Shoulder Arthroplasty",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Total Shoulder Arthroplasty + augmented glenoid component","Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components. A prosthetic component is also implanted to correct for the amount of bone loss in the shoulder and restore stability.",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Replacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed.",[15],[30],{"name":31,"affiliation":32,"role":33},"Peter Lapner, MD FRCSC","The Ottawa Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Katie McIlquham","CONTACT","613-737-8899","79839","kmcilquham@ohri.ca",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Ottawa","Ontario","K1H8L6","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-75.69812,45.41117,{"lat":53,"lon":52},[56,57,58],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":31,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"J Pollock, MD MSc FRCSC","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100476694","tsa-v-rsa-in-osteoarthritic-shoulders-with-greater-than-15-degrees-of-retroversion-100476694",false,"NCT05487274","TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion","Study Evaluating Reverse Versus Anatomic Total Shoulder Arthroplasty in Shoulders With Greater Than 15 Degrees of Retroversion in the Treatment of Osteoarthritis: Protocol","SERVASA15","Inclusion Criteria:\n\n1. Diagnosis of idiopathic shoulder OA.\n2. Patients who have failed standard non-surgical management of their shoulder OA who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for at least 6 months. Medical management will be defined as: a) The use of drugs including analgesics and nonsteroidal anti-inflammatory drugs, b) Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.), c) Activity modification\n3. Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss\n4. Patients with a glenoid deficiency and \\>15 degrees of glenoid retroversion up to a maximum of 26 degrees of glenoid retroversion (i.e. -15.1, -17, -20…etc.)\n5. 65 years of age and older\n\nExclusion Criteria:\n\n1. Active joint or systemic infection\n2. Rotator cuff arthropathy\n3. Significant muscle paralysis\n4. Charcot's arthropathy\n5. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)\n6. Unable to understand the consent form\u002Fprocess\n7. Pregnancy\n8. Psychiatric illness that precludes informed consent\n9. Unwilling to be followed for the duration of the study\n10. Retroversion cannot be surgically corrected to within 10 degrees of neutral\n11. History of previous shoulder surgery on affected side\n12. Rheumatoid arthritis in the affected shoulder","ALL","65 Years",{"count":74,"type":75},108,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study will compare total shoulder arthroplasty (TSA) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.",[81],"Osteoarthritis Shoulder",[83,84,85],"Shoulder Arthroplasty","Glenohumeral Osteoarthritis","Idiopathic Osteoarthritis","2024-04-29",{"date":88,"type":89},"2024-04-30","ACTUAL",{"date":91,"type":89},"2022-08-09",{"date":93,"type":75},"2029-12-31",{"name":5,"class":6},1]