[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100350203":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":46,"centralContacts":50,"locations":60,"responsibleParty":80,"collaborators":36,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":36,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":63,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Université de Montréal","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"TSA Standard","ACTIVE_COMPARATOR","This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used",[13],"Procedure: TSA standard",{"label":15,"type":10,"description":16,"interventionNames":17},"RTSA standard","This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used",[18],"Procedure: RTSA standard",{"label":20,"type":21,"description":22,"interventionNames":23},"TSA blueprint","EXPERIMENTAL","This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.",[24],"Procedure: TSA Blueprint",{"label":26,"type":21,"description":27,"interventionNames":28},"RTSA blueprint","This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.",[29],"Procedure: RTSA Blueprint",[31,37,39,43],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","TSA standard","Glenoid preparation will be done with 2D CT-Scan",[9],null,{"type":32,"name":15,"description":34,"armGroupLabels":38,"otherNames":36},[15],{"type":32,"name":40,"description":41,"armGroupLabels":42,"otherNames":36},"TSA Blueprint","Glenoid preparation will be done with Blueprint software",[20],{"type":32,"name":44,"description":34,"armGroupLabels":45,"otherNames":36},"RTSA Blueprint",[26],[47],{"name":48,"affiliation":5,"role":49},"Dominique Rouleau, MD","PRINCIPAL_INVESTIGATOR",[51,56],{"name":48,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","514-338-2222","2050","dominique_rouleau@yahoo.ca",{"name":57,"role":52,"phone":53,"phoneExt":58,"email":59},"Karine Tardif","3464","karinetardif2@gmail.com",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Hôpital du Sacré-Cœur de Montréal","RECRUITING","Montreal","Quebec","H4J 1C5","Canada","CA",{"type":70,"coordinates":71},"Point",[72,73],-73.58781,45.50884,{"lat":73,"lon":72},[76,78],{"name":77,"role":52,"phone":53,"phoneExt":54,"email":55},"Dominique Rouleau",{"name":57,"role":52,"phone":53,"phoneExt":79,"email":59},"3465",{"type":49,"investigatorFullName":77,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Orthopaedic surgeon","100350203","study-of-personalized-instrument-in-total-shoulder-arthroplasty-the-pitsa-study-100350203",false,"NCT03839758","Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study","Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study","PITSA","Inclusion Criteria:\n\n* Patients with shoulder osteaoarthritis and AVN\n\nExclusion Criteria:\n\n* Patients with previous shoulder arthroplasty\n* Patients with inflammatory arthritis and tumor\n* Patients with previous shoulder surgery with metal implant\n* Patients refusing 2-year follow-up\n* Patients that does not speak English or French\n* Patients with current or previous shoulder infection\n* Patients with graft during surgery","ALL","18 Years","99 Years",{"count":94,"type":95},112,"ESTIMATED","INTERVENTIONAL",[98],"NA","Total shoulder arthroplasty is an effective procedure to improve patients function and to relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this procedure is implanting the glenoid component. Indeed, surgical exposure is difficult and proper visualization of the glenoid is demanding. The current free-hand method is not precise and especially unreliable in glenoids with severe deformity. Inappropriate reaming and glenoid positioning can cause more bone loss during surgery.\n\nIn anatomic prostheses, glenoid component fixation is demanding and is the first component to present loosening at long term follow-up. When it comes to reverse arthroplasty, the glenoid component, once again, requires the most attention. Malpositioning of the glenosphere can cause notching, loosening, and instability.\n\nIn order to prevent these complications, precision in glenoid implantation is key. To this end, intraoperative computer navigation would be a helpful tool, but the increased expenses in computer equipment represent massive costs and possibly increases in surgical time. A more affordable option is a personalized guide, for which the only extra expense is the customized guide. These guides are based on precise 3D CT scan templates. Previous studies have evaluated the precision of the guide in vivo and in vitro, but none have measured it in a randomized study. As it represents additional costs, its efficacy needs to be proven before widespread use.\n\nThis method may also provide secondary benefits, such as decreasing operating time, lowering short- and long-term complications, and improving efficacy.\n\nThe objective of this study is to evaluate the performance of a patient specific glenoid guide.",[101],"Shoulder Arthritis",[103,104],"Prothesis","Glenoid implantation","2025-09-16",{"date":107,"type":108},"2025-09-22","ACTUAL",{"date":110,"type":108},"2019-10-08",{"date":112,"type":95},"2028-12",{"name":5,"class":6},1]