[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508900":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":33,"centralContacts":34,"locations":43,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":33,"enrollmentInfo":82,"targetDuration":33,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":46,"whyStopped":33,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Foundation for Orthopaedic Research and Education","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Kenalog with 0ml bupivacaine","EXPERIMENTAL","The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0ml of bupivacaine. The patients will be randomized into this group.",[13],"Drug: Kenalog with bupivacaine Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Kenalog with 4ml bupivacaine","The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,4ml of bupivacaine. The patients will be randomized into this group.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Kenalog with 0.25% bupivacaine","The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0.25% of bupivacaine. The patients will be randomized into this group.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Kenalog with bupivacaine Injection","Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.",[19,9,15],[29,30,31,32],"Knee Injection","Corticosteroid Injection","Kenalog","Bupivacaine",null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Anne Meredith Baldy, CCRC","CONTACT","(813)978-9700","ambaldy@foreonline.org",{"name":41,"role":37,"phone":38,"phoneExt":33,"email":42},"Debbi Warren, RN","dwarren@foreonline.org",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Florida Orthopaedic Institute","RECRUITING","Tampa","Florida","33637","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-82.45843,27.94752,{"lat":56,"lon":55},[59,63],{"name":60,"role":37,"phone":61,"phoneExt":33,"email":62},"Brian T Palumbo, MD","813-978-9700","bpalumbo@floridaortho.com",{"name":64,"role":37,"phone":38,"phoneExt":33,"email":65},"Thomas T Bernasek, MD","Tbernasek@floridaortho.com",{"type":67,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[69],{"name":45,"class":70},"NETWORK","100508900","phase-1-optimal-anesthetic-for-corticosteroid-injections-for-knee-osteoarthritis-100508900",false,"NCT05906433","Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis","Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.","Injections","Inclusion Criteria:\n\n1. Patients must be 18 years of age and be able to consent for themselves.\n2. OA grade Kellgren Lawrence Stage II or III.\n3. Diagnosis of primary osteoarthritis.\n\nExclusion Criteria:\n\n1. Patients with other forms of arthritis such as inflammatory arthritis.\n2. History of narcotic use for the past 6 months.\n3. Kellgren Lawrence arthritis grade 1 or 4.\n4. Pregnant women and prisoners.",true,"ALL","18 Years",{"count":83,"type":84},75,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","To evaluate pain relief from corticosteroid injection with and without anesthetic as well as with variable volume of anesthetic. Pain relief will be measured using the VAS pain score at the time of the injection as well as several time points following the injection to capture pain relief longevity. The investigators intend to evaluate how well the patients tolerate corticosteroid mixtures without anesthetic as well as with different volumes of anesthetic. Primary measure will be the time from procedure when postoperative status is considered success (as measured by global perceived improvement score).",[90],"Knee Osteoarthritis",[92,93,94],"knee injection","Knee osteoarthritis","corticosteroid","2024-12-04",{"date":97,"type":98},"2024-12-09","ACTUAL",{"date":100,"type":98},"2023-06-01",{"date":102,"type":84},"2025-12-01",{"name":5,"class":6},1]