[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658686":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":69,"studyPopulation":57,"armGroups":70,"interventions":83,"overallOfficials":93,"centralContacts":97,"locations":103,"responsibleParty":119,"collaborators":57,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":57,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":57,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":143,"whyStopped":57,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"The Second Affiliated Hospital of Kunming Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Total Perioperative Blood Loss","Total perioperative blood loss will be calculated in milliliters (mL) using perioperative hematologic measurements and estimated blood volume based on preoperative and postoperative laboratory values.","From preoperative baseline through postoperative day 3",[14,17,21,25,29,32,36,39,43,47,51,54],{"measure":15,"description":16,"timeFrame":12},"Maximum Decrease in Hemoglobin","Maximum decrease in hemoglobin from the preoperative value to the lowest postoperative value, expressed in g\u002FL.",{"measure":18,"description":19,"timeFrame":20},"Allogeneic Red Blood Cell Transfusion Rate","Proportion of participants who receive at least one allogeneic red blood cell transfusion from the start of surgery through hospital discharge.","From the start of surgery through hospital discharge,an anticipated average of 5-7 days.",{"measure":22,"description":23,"timeFrame":24},"Volume of Allogeneic Red Blood Cell Transfusion","Total volume of allogeneic red blood cells transfused from the start of surgery through hospital discharge.","From the start of surgery through hospital discharge，an anticipated average of 5-7 days.",{"measure":26,"description":27,"timeFrame":28},"Pain Intensity at Rest","Postoperative pain at rest will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.","Postoperative day 1, postoperative day 3",{"measure":30,"description":31,"timeFrame":28},"Pain Intensity During Activity","Postoperative pain during activity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.",{"measure":33,"description":34,"timeFrame":35},"Knee Swelling","Knee circumference measured 10 cm above the superior border of the patella.","Preoperative baseline, postoperative day 1, and postoperative day 3",{"measure":37,"description":38,"timeFrame":35},"Knee Range of Motion","Knee range of motion measured in degrees.",{"measure":40,"description":41,"timeFrame":42},"Knee Functional Score","Knee function will be assessed using the Hospital for Special Surgery (HSS) Knee Score. The total score ranges from 0 to 100, with higher scores indicating better knee function.","Within 24 hours before hospital discharge, 4 weeks after surgery, and 3 months after surgery",{"measure":44,"description":45,"timeFrame":46},"Length of Hospital Stay","Duration of postoperative hospitalization, expressed in days.","From the day of surgery through hospital discharge, an anticipated average of 5-7 days.",{"measure":48,"description":49,"timeFrame":50},"Symptomatic Deep Vein Thrombosis","Incidence of symptomatic deep vein thrombosis confirmed by vascular ultrasonography.","Up to 30 days after surgery",{"measure":52,"description":53,"timeFrame":50},"Symptomatic Pulmonary Embolism","Incidence of symptomatic pulmonary embolism confirmed by computed tomography pulmonary angiography when clinically indicated.",{"measure":55,"description":56,"timeFrame":50},"Other Postoperative Complications","Incidence of postoperative complications, including wound infection, wound drainage or poor healing, neurovascular injury, systemic allergic reaction, and abnormal liver or kidney function.",null,{"allocation":59,"interventionModel":60,"interventionModelDescription":61,"primaryPurpose":62,"observationalModel":57,"timePerspective":57,"maskingInfo":63},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either the intraosseous tranexamic acid group or the placebo control group and will remain in the assigned group throughout the study.","PREVENTION",{"masking":64,"maskingDescription":57,"whoMasked":65},"TRIPLE",[66,67,68],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Total knee arthroplasty may be associated with substantial perioperative blood loss. Tranexamic acid is commonly used to reduce bleeding during joint arthroplasty, but conventional systemic administration may result in greater systemic drug exposure. Local intraosseous administration may provide a higher drug concentration at the surgical site while limiting systemic exposure.\n\nThis study is a prospective, single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Seventy patients undergoing primary unilateral total knee arthroplasty for primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to an experimental group or a placebo control group.\n\nBefore skin incision, participants in the experimental group will receive tranexamic acid by local intraosseous injection into the cancellous bone of the tibial plateau and the medial and lateral condyles of the distal femur. Participants in the control group will undergo the same procedure using an equal volume of normal saline. Surgical technique, perioperative analgesia, rehabilitation, and other routine perioperative management will be standardized between the two groups.\n\nThe primary outcome is total perioperative blood loss, assessed using perioperative hematologic measurements through postoperative day 3. Secondary outcomes include postoperative hemoglobin reduction, transfusion rate and volume, postoperative pain, knee swelling, range of motion, functional recovery, length of hospital stay, and safety outcomes such as symptomatic deep vein thrombosis, pulmonary embolism, wound complications, infection, and other adverse events. Functional recovery will be assessed during follow-up through 3 months after surgery.",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Intraosseous Tranexamic Acid","EXPERIMENTAL","Participants assigned to this arm will receive a total dose of 2 g of tranexamic acid by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Tranexamic acid 1 g will be administered into the cancellous bone of the tibial plateau, and the remaining 1 g will be administered into the medial and lateral condyles of the distal femur. All other surgical, analgesic, and rehabilitation procedures will follow the standardized perioperative protocol.",[76],"Drug: Tranexamic Acid",{"label":78,"type":79,"description":80,"interventionNames":81},"Normal Saline Placebo","PLACEBO_COMPARATOR","Participants assigned to this arm will undergo the same intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty but will receive an equal volume of normal saline instead of tranexamic acid. All other surgical, analgesic, and rehabilitation procedures will be identical to those in the experimental arm.",[82],"Drug: Normal Saline",[84,89],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":57},"DRUG","Tranexamic Acid","A total dose of 2 g of tranexamic acid will be administered by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Of the total dose, 1 g will be injected into the cancellous bone of the tibial plateau, and 1 g will be injected into the medial and lateral condyles of the distal femur. The intervention will be administered using a standardized intraosseous injection technique.",[72],{"type":85,"name":90,"description":91,"armGroupLabels":92,"otherNames":57},"Normal Saline","Normal saline will be administered by the same local intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty. The volume, injection sites, timing, and administration procedure will be matched to those used in the experimental group.",[78],[94],{"name":95,"affiliation":5,"role":96},"Ning Lu","PRINCIPAL_INVESTIGATOR",[98],{"name":99,"role":100,"phone":101,"phoneExt":57,"email":102},"NIng Lu","CONTACT","+86-13888574273","luningwei2@163.com",[104],{"facility":5,"status":57,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Kunming","Yunnan","650000","China","CN",{"type":111,"coordinates":112},"Point",[113,114],102.71833,25.03889,{"lat":114,"lon":113},[117,118],{"name":95,"role":100,"phone":101,"phoneExt":57,"email":102},{"name":95,"role":96,"phone":57,"phoneExt":57,"email":57},{"type":96,"investigatorFullName":95,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"Associate Professor","100658686","phase-4-intraosseous-tranexamic-acid-for-reducing-blood-loss-in-total-knee-arthroplasty-100658686",false,"NCT07853885","Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee Arthroplasty","Efficacy and Safety of Local Intraosseous Tranexamic Acid Injection for Reducing Perioperative Blood Loss in Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial","Inclusion Criteria:\n\n* Age 50 to 85 years.\n* Diagnosis of primary knee osteoarthritis.\n* Scheduled to undergo primary unilateral total knee arthroplasty.\n* American Society of Anesthesiologists (ASA) physical status classification I to III.\n* Willing to participate in the study and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to tranexamic acid.\n* History of thromboembolic disease, including deep vein thrombosis or pulmonary embolism.\n* Known hypercoagulable state or current use of anticoagulant therapy, except for protocol-permitted perioperative anticoagulation\n* Severe cardiac, hepatic, or renal dysfunction.\n* History of vascular stent implantation or peripheral vascular disease.\n* Active infection or previous surgery on the study knee.\n* Abnormal coagulation function, including an international normalized ratio (INR) greater than 1.5.\n* Pregnancy or breastfeeding.","ALL","50 Years","85 Years",{"count":132,"type":133},70,"ESTIMATED","INTERVENTIONAL",[136],"PHASE4","This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). A total of 70 patients with primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to either the tranexamic acid group or the placebo control group. Before skin incision, participants in the experimental group will receive local intraosseous tranexamic acid, while participants in the control group will receive an equal volume of normal saline using the same injection procedure. The primary outcome is total perioperative blood loss. Secondary outcomes include postoperative hemoglobin reduction, transfusion requirements, pain, knee swelling, range of motion, functional recovery, length of hospital stay, and postoperative complications. Participants will be followed for up to 3 months after surgery.",[139],"Knee Osteoarthritis",[141,86,142],"Total Knee Arthroplasty","Intraosseous Injection","NOT_YET_RECRUITING","2026-10-06",{"date":146,"type":147},"2026-10-09","ACTUAL",{"date":149,"type":133},"2026-10",{"date":151,"type":133},"2027-07",{"name":5,"class":6},1]