[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07630896":3,"trial-entities:NCT07630896":110,"trial-summary:NCT07630896":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":49,"secondary_outcomes":57,"sex":70,"minimum_age":71,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":84,"locations":87,"central_contacts":102,"overall_officials":107,"references":108,"see_also_links":109},"NCT07630896","AAAV7556","Post-op Prednisone and Glucose Monitoring in TKA","Postoperative Prednisone Regimen in TKA and Its Effect on Continuous Glucose Levels","NOT_YET_RECRUITING","2028-03","2026-06","2026-06-05","2026-07-01","Columbia University","OTHER",false,"This study compares the efficacy of a 5-day post-operative oral prednisone regimen (40 mg daily) with the standard intraoperative steroid regimen, focusing on pain, swelling, range of motion, opioid use, and glucose levels monitored continuously.",null,[19,20,21],"Osteoarthritis","Unicompartmental Knee Arthroplasty","Total Hip Arthroplasty (THA)",[23,24,25],"Post-operative pain","Prednisone","Continuous Glucose Monitoring","INTERVENTIONAL","TREATMENT",[29],"PHASE4",{"count":31,"type":32},104,"ESTIMATED",[34,39,45],{"type":35,"name":24,"description":36,"armGroupLabels":37},"DRUG","40 mg daily for 5 days",[38],"Post-operative Steroids",{"type":40,"name":41,"description":42,"armGroupLabels":43},"DEVICE","Continuous Glucose Monitor","Provides real-time glucose readings for up to 14 days",[38,44],"Standard of care",{"type":14,"name":46,"description":47,"armGroupLabels":48},"InkWell Health Tattoos","Temporary medical-grade tattoos that provide real-time monitoring of knee swelling and range of motion",[38,44],[50,54],{"measure":51,"description":52,"timeFrame":53},"Pain at Rest","Pain intensity at rest will be measured using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a validated and standardized tool for assessing patient-reported pain.","2 weeks",{"measure":55,"description":56,"timeFrame":53},"Pain with Ambulation","Pain intensity with ambulation will be measured using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a validated and standardized tool for assessing patient-reported pain.",[58,61,63,65,67],{"measure":59,"description":60,"timeFrame":53},"Swelling","Knee joint circumference will be measured in centimeters at the joint line.",{"measure":62,"timeFrame":53},"Range of Motion",{"measure":64,"timeFrame":53},"Opioid Consumption",{"measure":66,"timeFrame":53},"Continuous Glucose Levels",{"measure":68,"description":69,"timeFrame":53},"Adverse Outcomes","Total number of adverse events related to steroid treatment will be recorded.","ALL","18 Years",{"inclusion":73,"exclusion":76,"raw_text":83},[74,75],"Undergoing Primary Unicompartmental Knee Arthroplasty or Total Hip Arthroplasty","Age 18 and above",[77,78,79,80,81,82],"Steroid therapy","Narcotic use within past 3 months","History of corticosteroid intolerance","Pregnancy","Uncontrolled diabetes","Doesn't own smart phone","Inclusion Criteria:\n\n* Undergoing Primary Unicompartmental Knee Arthroplasty or Total Hip Arthroplasty\n* Age 18 and above\n\nExclusion Criteria:\n\n* Steroid therapy\n* Narcotic use within past 3 months\n* History of corticosteroid intolerance\n* Pregnancy\n* Uncontrolled diabetes\n* Doesn't own smart phone\n\nDrop Criteria:\n\n\\- 2nd dose of IV dexamethasone",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"city":90,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":99},"Columbia University Irving Medical Center","New York","10032","United States",[94,97],{"name":95,"role":96},"Roshan Shah, MD","CONTACT",{"name":95,"role":98},"PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},40.71427,-74.00597,[103],{"name":104,"role":96,"phone":105,"email":106},"Jacqueline Lenahan","(212) 305-8193","jl5092@cumc.columbia.edu",[],[],[],{"nct_id":4,"conditions":111,"biomarkers":114},[112,19,113],"Arthroplasty, Replacement, Partial Knee","Total replacement of hip",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This interventional study plans to enroll 104 participants. It compares a 5-day prednisone regimen to standard care.","completed","Post-Surgery Prednisone and Glucose Monitoring for Joint Replacement","This study is looking at whether taking prednisone (a steroid) for 5 days after knee or hip replacement surgery helps with pain, swelling, and movement. It compares this to the usual steroid given during surgery. Researchers will also use a Continuous Glucose Monitor (a device that tracks blood sugar) and InkWell Health Tattoos (temporary tattoos that monitor swelling and movement) to see how these treatments affect your body. You might be able to join if you are 18 or older and are having a unicompartmental knee replacement or total hip replacement. The main goals are to see how much pain you have at rest and when walking, both measured at 2 weeks after surgery. The current recruitment status is unclear.","Your pain levels will be measured at 2 weeks after surgery.",120,"Not specified in the trial record.","Not stated in the trial record.",[24,41,46],"v2"]