[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470607":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":62,"collaborators":61,"id":64,"slug":61,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":61,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":61,"enrollmentInfo":72,"targetDuration":61,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":46,"whyStopped":61,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cingal","EXPERIMENTAL","A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide",[13],"Drug: Triamcinolone Hexacetonide and hyaluronic acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Cortisone","ACTIVE_COMPARATOR","A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25%",[19],"Drug: Triamcinolone Hexacetonide",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Triamcinolone Hexacetonide and hyaluronic acid","infiltration under fluoroscopy",[9],[9],{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":30},"Triamcinolone Hexacetonide",[15],[15],[32],{"name":33,"affiliation":34,"role":35},"Patrice Tétreault, MD FRCSC","CHUM","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Fidaa Al-Shakfa, M.Sc, MBA","CONTACT","5148908000","26103","f.alshakfa.crchum@gmail.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Centre Hospitalier de l'Université de Montréal (CHUM)","RECRUITING","Montreal","Quebec","H2X 0C1","Canada",{"type":52,"coordinates":53},"Point",[54,55],-73.58781,45.50884,{"lat":55,"lon":54},[58,60],{"name":59,"role":39,"phone":40,"phoneExt":41,"email":42},"Fidaa Al-Shakfa, M.Sc",{"name":33,"role":35,"phone":61,"phoneExt":61,"email":61},null,{"type":63,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100470607",false,"NCT05408065","Comparison of the Analgesic Effect of 2 Shoulder Infiltrations","A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate\u002FTriamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder.","Inclusion Criteria:\n\n* A clinical examination that confirms the radiological diagnosis of moderate to severe primary shoulder osteoarthritis, stage II and above, according to the Samilson-Prieto classification.\n* Patients aged between 20 and 90 years.\n* A patient with bilateral shoulder osteoarthritis will choose the side of the infiltration, only one side can be chosen to participate in the study.\n* The patient must have a clinical pain threshold of a minimum of 4\u002F10 on the visual analogue scale.\n* The patient must have the cognitive ability to read and fill out the questionnaires.\n* The patient must be able to read and understand French or English\n\nExclusion Criteria:\n\n* Presence of a transfixing rotator cuff tear assessed on MRI.\n* No previous shoulder reconstruction surgery.\n* Pregnant woman.\n* A patient who has received a cortisone infiltration within 6 months prior to the start of the study.\n* A patient who has received a platelet-rich plasma or a hyaluronic acid infiltration within 12 months prior to the start of the study.\n* Diagnosis of avascular necrosis.\n* Disease affecting the studied joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.)\n* Suspicion or presence of active local infectious process.\n* Presence or suspicion of neoplasia or local metastasis.\n* Severe trauma to the shoulder ( ≤ 3 months)\n* Significant cognitive impairment or insufficient language proficiency to adequately answer the questionnaires.\n* Any other serious medical condition that does not allow participation in the study or may be a contraindication to cortisone injection.","ALL","20 Years",{"count":73,"type":74},84,"ESTIMATED","INTERVENTIONAL",[77],"NA","For patients suffering of osteoarthritis, only analgesic treatments such as anti-inflammatory drugs and cortisone infiltrations provide significant but temporary relief of their pain. The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone). It is anticipated that the Cingal infiltration will have a greater analgesic effect than a simple cortisone infiltration in patients with moderate to severe osteoarthritis of the shoulder.\n\nMethod:\n\n* Randomized controlled trial\n* Monocentric\n* Randomization will be done using sealed envelopes",[80,81],"Infiltration","Shoulder Osteoarthritis",[83,84,85],"infiltration","Osteoarthritis","hyaluronic acid","2024-02-09",{"date":88,"type":89},"2024-02-12","ACTUAL",{"date":91,"type":89},"2022-11-15",{"date":93,"type":74},"2026-12",{"name":5,"class":6},1]